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

    HANDLE, SCALPEL, STAINLESS STEEL

    K Number: K760364 · Decision Sep 13, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    300
    Registration Numbers
    300
    Same Product Code
    47
    Applicant Total
    5
    Review Days
    42

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    Basic Information

    Device Name
    HANDLE, SCALPEL, STAINLESS STEEL
    K Number
    K760364
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Aeroceuticals
    Date Received
    August 2, 1976
    Decision Date
    September 13, 1976
    Product Code
    GES
    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
    GES Blade, Scalpel

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    Other Clearances by Aeroceuticals

    K Number Device Name
    K770217 LANCE LTD. STERI. STITCH CUTTER BLADE
    K760363 SCALPEL, SURGICAL, STERILE STAINLESS
    K760361 BLADE, SURGICAL SCALPEL, STERILE
    K760362 LANCET, BLOOD, STERILE STAINLESS STEEL