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

    GOWN, BOUNDARY SINGLE USE REINFORCED

    K Number: K760237 · Decision Aug 11, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    72
    Review Days
    27

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    Basic Information

    Device Name
    GOWN, BOUNDARY SINGLE USE REINFORCED
    K Number
    K760237
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Procter & Gamble Mfg. Co.
    Date Received
    July 15, 1976
    Decision Date
    August 11, 1976
    Product Code
    FYA
    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
    FYA Gown, Surgical

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    K864673 UNSCENTED MENSTRUAL PAD
    K861863 MODIFIED PROTECTIVE GARMENT
    K862348 SINGLE-USE PATIENT UNDERPAD
    K860598 MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS
    K853880 ATTENDS DISPOS. UNDERPAD
    K853000 SCENTED ALWAYS PANTILINERS
    K852985 UNSCENTED ALWAYS PANTILINERS
    K850956 ALWAYS MAXIPADS - SCENTED
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