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510(k) Data Aggregation

    K Number
    K132819
    Device Name
    PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
    Manufacturer
    PLAYTEX MANUFACTURING INC.
    Date Cleared
    2013-10-09

    (30 days)

    Product Code
    HIL, HEB
    Regulation Number
    884.5460
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLAYTEX MANUFACTURING INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Playtex scented (or scented deodorized) and unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid. Absorbency Ranges: Absorbs menstrual flow < 6 grams (Light) Absorbs menstrual flow 6-9 grams (Regular) Absorbs menstrual flow 9-12 grams (Super) Absorbs menstrual flow 12-15 grams (Super Plus)
    Device Description
    Scented (or scented deodorized) and unscented menstrual tampons for the absorption of menstrual fluid. The tampon consists of a pledget, string and applicator (barrel and plunger).
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    K Number
    K111684
    Device Name
    PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
    Manufacturer
    PLAYTEX MANUFACTURING INC.
    Date Cleared
    2012-02-03

    (233 days)

    Product Code
    HIL
    Regulation Number
    884.5460
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLAYTEX MANUFACTURING INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Playtex scented or scented deodorized menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid; Playtex unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
    Device Description
    Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.
    Ask a Question

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