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

    DRAPE PACKS, SURGICAL GOWNS

    K Number: K790234 · Decision Feb 22, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    10
    Review Days
    20

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    Basic Information

    Device Name
    DRAPE PACKS, SURGICAL GOWNS
    K Number
    K790234
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Convertors
    Date Received
    February 2, 1979
    Decision Date
    February 22, 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
    K780627 SURG-O-PAK, GOWNS, SHEETS, AND TOWELS
    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