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510(k) Data Aggregation

    K Number
    K091178
    Device Name
    MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN
    Manufacturer
    MTP MEDICAL TECHNICAL PROMOTION GMBH
    Date Cleared
    2009-07-31

    (100 days)

    Product Code
    MMP
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    MMP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MTP Disposable Equipment Covers, KARL STORZ 15" Touch Screen are intended to cover equipment used in medical settings in order to maintain a sterile field and as an aid in the clean up of equipment after surgery. The covers are not intended to be used as patient drapes and have no patient contact.
    Device Description
    MTP Disposable Equipment Covers, KARL STORZ 15" Touch Screen
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    K Number
    K043234
    Device Name
    LIGHT DRAPE
    Manufacturer
    WRAPPED IN COMFORT
    Date Cleared
    2005-05-25

    (184 days)

    Product Code
    MMP
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    MMP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Light Drapes are designed to cover and enhance the outer appearance of phototherapy light fixtures.
    Device Description
    Light Drape (accessory to Neonatal Phototherapy Light)
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    K Number
    K041501
    Device Name
    GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS
    Manufacturer
    GUANGZHOU FORTUNIQUE LTD.
    Date Cleared
    2004-11-30

    (176 days)

    Product Code
    MMP, KKX
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    MMP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Guangzhou Fortunique's Drapes, Bags and Covers are intended to cover equipment, to maintain a sterile field and as an aid in the clean up of equipment after surgery or other medical procedures. These drapes, bags and covers are not intended to be used as patient drapes and they have no patient contact. Fortunique intends to manufacture and market Drapes, Bags and Covers sterile in ready to use form and will also provide them in non-sterile form to other companies for inclusion in convenience packages which they will then sterilize.
    Device Description
    Guangzhou Fortunique Drapes, Bags and Covers are made of low density polyethylene film ir various sizes and shapes for use in covering equipment. These drapes, bags and covers are offered non-sterile in bulk quantities and sterile in individual packs.
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    K Number
    K040794
    Device Name
    INCUBATOR CAPE
    Manufacturer
    WRAPPED IN COMFORT
    Date Cleared
    2004-06-10

    (73 days)

    Product Code
    MMP
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    MMP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Incubator Capes are designed to cover and enhance the outer appearance of an incubator.
    Device Description
    Incubator Cover (accessory to Incubators)
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    K Number
    K032065
    Device Name
    MEDLINE BAND BAGS AND EQUIPMENT COVERS
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2003-09-22

    (81 days)

    Product Code
    MMP
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    MMP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medline Band Bags and Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. These covers are not intended to be used as patient drapes and have no patient contact.
    Device Description
    Not Found
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    K Number
    K023540
    Device Name
    SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09
    Manufacturer
    VALUMED
    Date Cleared
    2003-02-04

    (105 days)

    Product Code
    MMP
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    MMP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The various sizes of Polyethylene Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. These covers are not intended to be used as patient drapes and do not have patient contact.
    Device Description
    ValuMed's Cover Alls, the Sterile Equipment Covers by Custom Medical Products(K931417), Equipment Covers by United States Surgical(K964699) and the Equipment Snap Covers by Advance Medical Designs(K850959) consist of various sizes and shapes of polvethvlene covers that are positioned on surgical equipment. The covers are used to maintain a sterile field and as an aid in the clean up of equipment after surgery.
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    K Number
    K014239
    Device Name
    MEDSURG EQUIPMENT COVERS
    Manufacturer
    INTERNATIONAL MEDSURG CONNECTION
    Date Cleared
    2002-02-19

    (55 days)

    Product Code
    MMP
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    MMP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These equipment covers are equipment drapes or drape accessories made of natural or synthetic materials intended to be used as a protective patient covering such as to isolate a site of surgical incision from microbial and other contamination.
    Device Description
    The International Medsurg Connections equipment covers are made of polyethylene. The covers are offered sterile and non-sterile.
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    K Number
    K970885
    Device Name
    ULTRASOUND SYSTEMS DRAPE
    Manufacturer
    PROTEK MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-09-22

    (195 days)

    Product Code
    MMP
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    MMP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultrasound System Drape Kit - Polyethylene Drapes for covering Monitors, Keyboards, Floorpedals, and Equipment Arms
    Device Description
    Not Found
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    K Number
    K962288
    Device Name
    COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER
    Manufacturer
    PINNACLE PRODUCTS, INC.
    Date Cleared
    1997-01-30

    (230 days)

    Product Code
    MMP
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    MMP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These products have the same intended use, to act as a physical barrier, augmenting existing infection control techniques and make clean-up and disinfection easier. These are the same as those of the predicate devices. These products also have the same intended uses as similar products currently cleared for marketing by the 510(k) process.
    Device Description
    These disposable plastic shields are for use with various small hand-held dental instruments such as handpieces, ultrasonic scalers, jet polishers, contra angle handpieces, and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, headpieces, accessory trays, x-ray heads, and others. They are manufactured from clear polyethylene and formed to provide excellent tactile control combined with simple coverage and removal from the instrument. These shields act as as physical barriers which augment existing infection control techniques and simplify existing clean-up and disinfection methods. They do not obviate, in any way, existing good dental practices such as sterilizing handpieces, hand instruments, etc between each patient. The various products are designed to slip over the ends of the respective devices, allowing for attachment and/or protrusion of those parts of the devices that are inserted into the patient's mouth (instruments), or otherwise contact the patient (chair covers). The products will be sold non-sterile, prepackaged, and are disposable, single use only.
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    K Number
    K961699
    Device Name
    EQUIPMENT COVERS
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Cleared
    1996-08-23

    (113 days)

    Product Code
    MMP
    Regulation Number
    878.4370
    Why did this record match?
    Product Code :

    MMP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Both the Auto Suture* Equipment Covers™ and the Sterile INTENDED USE: Equipment Covers by Custom Medical Products (K931417) are intended to cover equipment and are not intended to be as patient drapes or have patient contact.
    Device Description
    Both the Auto Suture* Equipment Covers™ and the Sterile Equipment Covers by Custom Medical Products (K931417) consist of various sizes and shapes of polyethylene covers which are positioned on surgical equipment. The covers are used to maintain the surgeons sterile field and as an aid in the clean up of equipment after surgery.
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