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

    PLAYTEX SUPER TAMPONS & SUPER DEODORANT TAMPONS

    K Number: K851356 · Decision Apr 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    188
    Applicant Total
    10
    Review Days
    8

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PLAYTEX SUPER TAMPONS & SUPER DEODORANT TAMPONS
    K Number
    K851356
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5470
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Playtex, Inc.
    Date Received
    April 4, 1985
    Decision Date
    April 12, 1985
    Product Code
    HEB
    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
    HEB Tampon, Menstrual, Unscented

    Similar 510(k) Clearances

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

    Livi Device

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

    Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons

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

    COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS

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

    Unscented menstrual three-piece applicator tampon

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

    Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons

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

    SABA 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
    K861738 PLAYTEX TAMPONS
    K854258 PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA
    K852063 PLAYTEX SLENDER REG. TAMPONS & 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