BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY

    K Number: K894939 · Decision Dec 8, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    47
    Same Product Code
    58
    Applicant Total
    16
    Review Days
    127

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    Basic Information

    Device Name
    PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY
    K Number
    K894939
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    North American Sterilization & Packaging Co.
    Date Received
    August 3, 1989
    Decision Date
    December 8, 1989
    Product Code
    FPD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FPD Tube, Feeding

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    K925593 NORTEC STERILE WATER FOR DEVICE IRRIGATION
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    K911865 NORTEC CONNECTING TUBE SET
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