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510(k) Data Aggregation

    K Number
    K970465
    Device Name
    BOUSER'S URINAL
    Manufacturer
    GENERAL POLYMERS
    Date Cleared
    1997-12-18

    (314 days)

    Product Code
    EXJ
    Regulation Number
    876.5250
    Why did this record match?
    Product Code :

    EXJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To collect urine to provide assistance for male urinary incontinence. This device is intended for non-prescription use and it is re-usable after cleaning and washing. It is intended for non probanpuen ass annected to an indwelling catheter. This device is not designed for pediatric use.
    Device Description
    Not Found
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    K Number
    K972100
    Device Name
    VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)
    Manufacturer
    ADVANCED CARE MEDICAL PRODUCTS
    Date Cleared
    1997-07-31

    (57 days)

    Product Code
    EXJ
    Regulation Number
    876.5250
    Why did this record match?
    Product Code :

    EXJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970966
    Device Name
    COMFORT CATH CHOICE MALE EXTERNAL CATHETER
    Manufacturer
    SIERRA LABORATORIES, INC.
    Date Cleared
    1997-04-22

    (36 days)

    Product Code
    EXJ
    Regulation Number
    876.5250
    Why did this record match?
    Product Code :

    EXJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963265
    Device Name
    PROSYS SAMEC LA
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
    Date Cleared
    1996-10-25

    (66 days)

    Product Code
    EXJ
    Regulation Number
    876.5250
    Why did this record match?
    Product Code :

    EXJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProSys™ SAMEC™ LA is intended for use in the management of male urinary incontinence.
    Device Description
    ProSys™ SAMEC™ LA is a one-piece self-adhering male external catheter.
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    K Number
    K962900
    Device Name
    SELF RETAINING MALE EXTERNAL URINARY CATHETER
    Manufacturer
    HOLLISTER, INC.
    Date Cleared
    1996-09-16

    (53 days)

    Product Code
    EXJ
    Regulation Number
    876.5250
    Why did this record match?
    Product Code :

    EXJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hollister Self Retaining Male External Catheter is a urosheath type incontinence device intended to be used as an external catheter to collect urine from urinary incontinent males.
    Device Description
    The Hollister Self Retaining Male External Urinary Catheter is a condom-like device made from Natural Rubber Latex. The device features a unique inner flap that aids in the protection of the penile skin from irritation due to backwash of urine and helps to maximize wear time. The external catheter is presented on a plastic collar to enable easy application and maintain the catheter shape integrity during shipping.
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    K Number
    K962384
    Device Name
    COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER
    Manufacturer
    SIERRA LABORATORIES, INC.
    Date Cleared
    1996-07-15

    (25 days)

    Product Code
    EXJ
    Regulation Number
    876.5250
    Why did this record match?
    Product Code :

    EXJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K962413
    Device Name
    COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER
    Manufacturer
    SIERRA LABORATORIES, INC.
    Date Cleared
    1996-07-15

    (24 days)

    Product Code
    EXJ
    Regulation Number
    876.5250
    Why did this record match?
    Product Code :

    EXJ

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

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