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

    SKIN MESH DEVICE

    K Number: K861285 · Decision Apr 17, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    10

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SKIN MESH DEVICE
    K Number
    K861285
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Precision Modified Devices
    Date Received
    April 7, 1986
    Decision Date
    April 17, 1986
    Product Code
    GFD
    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
    GFD Dermatome

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GFD), ordered by most recent decision date.

    DMS-1000C DERMOABRADER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DERMTOME BLADE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DECA DERMATOME (MICROMOTOR SYSTEM)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PADGETT AIR DERMATOME, MODEL A

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AESCULAP ACCU-DERMATOME

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all