BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CHERMEL SCALP VEIN SET

    K Number: K851516 · Decision Aug 23, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    7
    Review Days
    130

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    Basic Information

    Device Name
    CHERMEL SCALP VEIN SET
    K Number
    K851516
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Cher Mel Corp.
    Date Received
    April 15, 1985
    Decision Date
    August 23, 1985
    Product Code
    FPA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FPA Set, Administration, Intravascular

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    Other Clearances by Cher Mel Corp.

    K Number Device Name
    K863040 DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS
    K842203 LITTMAN TYPE SH-6010, NURSE TYPE
    K843324 SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH
    K842822 CHERMEL BONE GOUGES
    K842823 CHERMEL OSTEOTOMES
    K842824 CHERMEL BONE CHISELS