BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    X-RAY DETECTABLE LAP SPONGES

    K Number: K812651 · Decision Oct 20, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    110
    Applicant Total
    72
    Review Days
    33

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    Basic Information

    Device Name
    X-RAY DETECTABLE LAP SPONGES
    K Number
    K812651
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4450
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Procter & Gamble Mfg. Co.
    Date Received
    September 17, 1981
    Decision Date
    October 20, 1981
    Product Code
    GDY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GDY Gauze/Sponge, Internal, X-Ray Detectable

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    Other Clearances by Procter & Gamble Mfg. Co.

    K Number Device Name
    K873457 SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
    K873036 ATTENDS INCONTINENT BRIEF
    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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