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

    PLAYTEX ULTIMATES TAMPONS

    K Number: K932909 · Decision Mar 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    27
    Same Product Code
    83
    Applicant Total
    17
    Review Days
    264

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    Basic Information

    Device Name
    PLAYTEX ULTIMATES TAMPONS
    K Number
    K932909
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5460
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Playtex Family Products, Inc.
    Date Received
    June 16, 1993
    Decision Date
    March 7, 1994
    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 Playtex Family Products, Inc.

    K Number Device Name
    K941196 PLATEX TAMPONS MODEL NUMBER 07094
    K940821 PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED
    K936189 PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED
    K932907 PLAYTEX ULTIMATES TAMPONS
    K935276 PLAYTEX NON-DEODORANT TAMPONS, PLAYTEX DEODORANT TAMPONS
    K934083 PLAYTEX ULTIMATES TAMPONS
    K922834 TAMPONS, NATURAL ODOR PROT. VARIOUS ABSORBENCY
    K924279 PLAYTEX FLUSHABLE TAMPONS, REGULAR, SUPER, SUPER +
    K914438 PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS
    K912002 PLAYTEX NON-DEODORANT/DEODORANT TAMPONS
    Search all 17 clearances from Playtex Family Products, Inc. →