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

    PEDIATRICS GOWN

    K Number: K771929 · Decision Nov 16, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    10
    Review Days
    33

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    Basic Information

    Device Name
    PEDIATRICS GOWN
    K Number
    K771929
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Convertors
    Date Received
    October 14, 1977
    Decision Date
    November 16, 1977
    Product Code
    FYB
    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
    FYB Gown, Patient

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    PROCEDURE & RECOVERY PATIENT SUIT

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    SHIELD DISP. PATIENTS PONCHO GOWNS

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    Other Clearances by Convertors

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