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

    RELY TAMPON

    K Number: K761184 · Decision Dec 17, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    27
    Same Product Code
    83
    Applicant Total
    72
    Review Days
    14

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    Basic Information

    Device Name
    RELY TAMPON
    K Number
    K761184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5460
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Procter & Gamble Mfg. Co.
    Date Received
    December 3, 1976
    Decision Date
    December 17, 1976
    Product Code
    HIL
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIL Tampon, Menstrual, Scented, Scented-Deodorized

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HIL), ordered by most recent decision date.

    ONTEX AND OTHERS PROPRIETARY NAMES

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    PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS

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    PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD

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    TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED

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    PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS

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    FDA Class 2 ·Obstetrics/Gynecology
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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
    Search all 72 clearances from Procter & Gamble Mfg. Co. →