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510(k) Data Aggregation

    K Number
    K011755
    Device Name
    STRYKER T4 HYTREL (R) TOGAS
    Manufacturer
    STRYKER CORP.
    Date Cleared
    2001-06-22

    (16 days)

    Product Code
    LYU
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    LYU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker Hytrel® Zippered Toga and Pull-over Toga are components of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
    Device Description
    The Stryker T4 Personal Protection System: Stryker Hytrel® T4 Togas.
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    K Number
    K965237
    Device Name
    NURSES BOUFFANT CAP
    Manufacturer
    COPIOUMED INTL., INC.
    Date Cleared
    1997-08-27

    (239 days)

    Product Code
    LYU
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    LYU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.
    Device Description
    CAP, BOUFFANT, NURSES SURGICAL WHITE, BLUE, & GREEN
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    K Number
    K970988
    Device Name
    FAR-EAST BOUFFANT CAPS
    Manufacturer
    FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
    Date Cleared
    1997-07-10

    (114 days)

    Product Code
    LYU
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    LYU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Far-East Bouffant Caps are disposable devices, intended for medical purposes, that are worn by operating room personnel during surgical procedures to protect form surgical patient and operating room personnel from Burgioal patient and open commons and particulate materials.
    Device Description
    Far-East Bouffant Caps are disposable devices, intended for medical purposes, that are worn by operating room personnel during surgical procedures to protect form surgical patient and operating room personnel from Burgioal patient and open commons and particulate materials.
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    K Number
    K964364
    Device Name
    DISPOSABLE APRON
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Date Cleared
    1997-02-25

    (116 days)

    Product Code
    LYU
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    LYU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Apron will be used in indications which are the same for that of other aprons. Specifically, the Disposable Apron is intended to be used the hospital environment to protect the healtheare worker from the transfer of micro-organisms. blood, body fluids and particulate material between the worker and the patient. The Disposable Apron is a disposable product intended for single use only.
    Device Description
    The Disposable Apron is manufactured from 6 gauge Poly Vinyl and is available in a "onc size fits most" size The apron is secured by heing slipped over the head and tied in back
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    K Number
    K961791
    Device Name
    DEPUY DISPOSABLE FILTER/HOOD
    Manufacturer
    DEPUY, INC.
    Date Cleared
    1996-08-09

    (92 days)

    Product Code
    LYU
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    LYU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DePuy Disposable Filter/Hood is intended to be used with the Stryker Steri-Shield System as disposable surgical apparel to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
    Device Description
    The DePuy Disposable Filter/Hood is a single use, disposable hood with faceshield. The hood is constructed of Dexter paper with spun polypropylene filter media located at the top and back of the hood. The DePuy hood is designed to fit over the Stryker Steri-Shield helmet so that all intake and exhaust air passes through the filter material.
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    K Number
    K961454
    Device Name
    AMMI MAGNI-GUARD
    Manufacturer
    AMERICAN MEDICAL MFG., INC.
    Date Cleared
    1996-07-25

    (101 days)

    Product Code
    LYU
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    LYU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Magni-Guard functions in the same manner as predicate devices in that it provides protection to the surgical staff during surgical procedures.
    Device Description
    Magni-Guard includes the same components as other marketed predicate devices. The concept of use is to hold it with one hand over a surgical site before releasing clamps from blood vessel grafts or during heavy irrigation to prevent blood splashing. The basic scientific concept that forms the Magni-Guard is that it consists of a clear, rigid, see through plastic. The Guard is made from styrene or PETG. The clear guard has raised side walls throughout its circumference (identical to a Petri-Dish) to prevent the splashing of blood across the surgical suite. It further has an extended handle attached to the circular guard for the surgical site as required intermittently during the surgical procedure.
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    K Number
    K945302
    Device Name
    SLOAN STA-DRI PANT PROTECTOR
    Manufacturer
    SLOAN CORP.
    Date Cleared
    1996-03-19

    (567 days)

    Product Code
    LYU
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    LYU

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

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