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

    PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS

    K Number: K132819 · Decision Oct 9, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    27
    Same Product Code
    83
    Applicant Total
    3
    Review Days
    30

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    Basic Information

    Device Name
    PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
    K Number
    K132819
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.5460
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Playtex Manufacturing, Inc.
    Date Received
    September 9, 2013
    Decision Date
    October 9, 2013
    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, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS

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    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Playtex Manufacturing, Inc.

    K Number Device Name
    K180167 Playtex Stella Tampons
    K111684 PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD