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

    SURGICAL HEAD DRAPE, DISP.

    K Number: K771136 · Decision Jul 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    449
    Applicant Total
    72
    Review Days
    21

    Basic Information

    Device Name
    SURGICAL HEAD DRAPE, DISP.
    K Number
    K771136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    PROCTER & GAMBLE MFG. CO.
    Date Received
    June 23, 1977
    Decision Date
    July 14, 1977
    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 PROCTER & GAMBLE MFG. CO.

    K Number Device Name
    K873036 ATTENDS INCONTINENT BRIEF
    K873457 SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
    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
    K850955 ALWAYS MAXIPADS - UNSCENTED
    Search all 72 clearances from PROCTER & GAMBLE MFG. CO. →