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510(k) Data Aggregation

    K Number
    K022306
    Device Name
    AART SILICONE TUBING
    Manufacturer
    AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.
    Date Cleared
    2002-10-10

    (86 days)

    Product Code
    KGZ
    Regulation Number
    878.4200
    Why did this record match?
    Product Code :

    KGZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K974295
    Device Name
    BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING
    Manufacturer
    BYRON MEDICAL
    Date Cleared
    1998-02-10

    (88 days)

    Product Code
    KGZ
    Regulation Number
    878.4200
    Why did this record match?
    Product Code :

    KGZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tubing Indications for use are general surgical fluid, exudate, rne Tubing me aspiration and general surgical fluid irrigation/infiltration.
    Device Description
    The principles of operation and technology incorporated in the Tubing are equivalent to other standard surgical tubing that acts as a pathway between the operative site and either an aspiration or irrigation source for fluid or soft tissue removal and fluid delivery.
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    K Number
    K973183
    Device Name
    WOUND DRAINAGE HOLDER
    Manufacturer
    R & D MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-01-23

    (151 days)

    Product Code
    KGZ
    Regulation Number
    878.4200
    Why did this record match?
    Product Code :

    KGZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The wound drainage reservoir holder is to be used when the patent is using a Jackson-Pratt 100cc Suction Reservoir and would prefer to have the reservoir attached directly against his or her body instead of attaching it with a safety pin to one of the clothing garments they are wearing.
    Device Description
    Wound Drainage Holder
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    K Number
    K955433
    Device Name
    DURALASTIC SILICONE TUBING
    Manufacturer
    ALLIED BIOMEDICAL CORP.
    Date Cleared
    1996-01-26

    (59 days)

    Product Code
    KGZ
    Regulation Number
    878.4200
    Why did this record match?
    Product Code :

    KGZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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