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510(k) Data Aggregation

    K Number
    K180167
    Device Name
    Playtex Stella Tampons
    Manufacturer
    Playtex Manufacturing, Inc.
    Date Cleared
    2018-05-30

    (128 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Playtex Manufacturing, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Playtex® unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
    Device Description
    The subject devices, which are modified from the predicate devices, are unscented menstrual tampons consisting of a tampon (pledget with string) and an applicator. The tampons are made of rayon fiber and have absorbency ranges: regular (6-9 grams) and super (9-12 grams). The applicators are made of polyethylene and polypropylene and have four color versions.
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