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

    PLAYTEX TAMPONS

    K Number: K861738 · Decision Jul 22, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    27
    Same Product Code
    83
    Applicant Total
    10
    Review Days
    77

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    Basic Information

    Device Name
    PLAYTEX TAMPONS
    K Number
    K861738
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5460
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Playtex, Inc.
    Date Received
    May 6, 1986
    Decision Date
    July 22, 1986
    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

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Intl. Playtex, Inc.

    K Number Device Name
    K871197 PLAYTEX TAMPONS AND DEODORANT TAMPONS
    K854258 PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA
    K852063 PLAYTEX SLENDER REG. TAMPONS & DEODORANT TAMPONS
    K851356 PLAYTEX SUPER TAMPONS & SUPER DEODORANT TAMPONS
    K851355 PLAYTEX SUPER PLUS TAMPONS & DEODORANT TAMPONS
    K782111 PADS, MINI, MAXI DEODORANT
    K782112 PADS, MINI, MAXI
    K760425 TAMPON, PLAYTEX 2 VERSION A
    K760426 TAMPON, PLAYTEX 2 VERSION B