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

    AMERICAN BRAIN RETRACTOR COVER

    K Number: K872951 · Decision Sep 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    22
    Applicant Total
    14
    Review Days
    50

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    Basic Information

    Device Name
    AMERICAN BRAIN RETRACTOR COVER
    K Number
    K872951
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    American Silk Sutures, Inc.
    Date Received
    July 28, 1987
    Decision Date
    September 16, 1987
    Product Code
    GET
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GET Motor, Surgical Instrument, Pneumatic Powered

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    Other Clearances by American Silk Sutures, Inc.

    K Number Device Name
    K922143 AMERICAN BURN SHEET
    K904514 STRUNG TELFA NON-ADHERENT SPONGE
    K902921 RAYON NEUROLOGICAL SPONGE
    K872810 STRUNG DENTAL ROLLS
    K872905 AMERICAN NASAL SPONGE
    K872906 SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE
    K872809 GAUZE CHERRY SPONGE
    K872808 CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8
    K872806 STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG
    K872807 NON-WOVEN TRACHEOTOMY SPONGE
    Search all 14 clearances from American Silk Sutures, Inc. →