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

    SURG-O-PAK, GOWNS, SHEETS, AND TOWELS

    K Number: K780627 · Decision Jul 11, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    10
    Review Days
    453

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    Basic Information

    Device Name
    SURG-O-PAK, GOWNS, SHEETS, AND TOWELS
    K Number
    K780627
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Convertors
    Date Received
    April 14, 1978
    Decision Date
    July 11, 1979
    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, Antimicrobial

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    Other Clearances by Convertors

    K Number Device Name
    K790234 DRAPE PACKS, SURGICAL GOWNS
    K781959 SURGICAL GOWNS, SHEETS
    K781534 SURG-O-PAK PREP PAD
    K781099 SURGICAL GOWNS AND DRAPES
    K780169 MASK, SURGICAL
    K771929 PEDIATRICS GOWN
    K770933 BIO-SHIELD CSR WRAP
    K770346 ORTHOPEDIC STOCKINETTE
    K761034 SURGEX SURGICAL SPONGE