BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GUARDIAN GEL, SURGEON'S GLOVING CREAM

    K Number: K910687 · Decision Oct 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    5
    Review Days
    234

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    Basic Information

    Device Name
    GUARDIAN GEL, SURGEON'S GLOVING CREAM
    K Number
    K910687
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4470
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Guardian Angel Products, Inc.
    Date Received
    February 19, 1991
    Decision Date
    October 11, 1991
    Product Code
    KGQ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KGQ Cream, Gloving, Surgeon'S

    Other Clearances by Guardian Angel Products, Inc.

    K Number Device Name
    K030547 MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE
    K923840 NEEDLE-GRABBER
    K923835 THE ELEVENTH FINGER
    K896985 ZAP-GUARD