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

    PLAYTEX DEODORANT TAMPONS, MODEL 34902

    K Number: K020201 · Decision Mar 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    27
    Same Product Code
    83
    Applicant Total
    17
    Review Days
    49

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    Basic Information

    Device Name
    PLAYTEX DEODORANT TAMPONS, MODEL 34902
    K Number
    K020201
    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 Products, Inc.
    Date Received
    January 22, 2002
    Decision Date
    March 12, 2002
    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 Products, Inc.

    K Number Device Name
    K073662 PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
    K072376 PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS
    K070745 MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS
    K061013 PLAYTEX EMBRACE PETITE BREAST PUMP
    K060981 PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
    K032636 PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
    K022594 PLAYTEX BREAST PUMP
    K022882 MODIFICATION TO PLAYTEX TAMPONS #24002
    K020200 PLAYTEX DEODORANT TAMPONS, MODEL 34802
    K020202 PLAYTEX DEODORANT TAMPONS, MODEL 34702
    Search all 17 clearances from Playtex Products, Inc. →