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

    REPAK SURGICAL PACKS

    K Number: K903908 · Decision Oct 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    449
    Applicant Total
    2
    Review Days
    64

    Basic Information

    Device Name
    REPAK SURGICAL PACKS
    K Number
    K903908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    REPACK SURGICAL ENTERPRISES, INC.
    Date Received
    August 23, 1990
    Decision Date
    October 26, 1990
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    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
    KKX Drape, Surgical

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    Other Clearances by REPACK SURGICAL ENTERPRISES, INC.

    K Number Device Name
    K880942 REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC)