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

    ELANTEC'S SURGICAL TAPE REMOVER

    K Number: K902009 · Decision Aug 29, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    118

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    Basic Information

    Device Name
    ELANTEC'S SURGICAL TAPE REMOVER
    K Number
    K902009
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4730
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Elantec, Inc.
    Date Received
    May 3, 1990
    Decision Date
    August 29, 1990
    Product Code
    KOX
    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
    KOX Solvent, Adhesive Tape

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