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

    CHERMEL OSTEOTOMES

    K Number: K842823 · Decision Aug 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    5
    Applicant Total
    7
    Review Days
    14

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    Basic Information

    Device Name
    CHERMEL OSTEOTOMES
    K Number
    K842823
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Cher Mel Corp.
    Date Received
    July 19, 1984
    Decision Date
    August 2, 1984
    Product Code
    GFI
    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
    GFI Osteotome, Manual

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    Other Clearances by Cher Mel Corp.

    K Number Device Name
    K863040 DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS
    K851516 CHERMEL SCALP VEIN SET
    K842203 LITTMAN TYPE SH-6010, NURSE TYPE
    K843324 SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH
    K842822 CHERMEL BONE GOUGES
    K842824 CHERMEL BONE CHISELS