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    K Number
    K180850
    Device Name
    re.t.a Reuseable Tampon Applicator
    Manufacturer
    Thinx, Inc.
    Date Cleared
    2018-08-20

    (140 days)

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

    Thinx, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The re.t.a.™ reusable tampon applicator in intended to be used to insert a digital menstrual tampon into the vagina.
    Device Description
    The re.t.a.™ Reusable Tampon Applicator is a non-sterile, single user reusable device. It is intended to be sold on its own, without a pre-loaded tampon. The applicator requires the user to insert a legally-marketed digital/non-applicator menstrual tampon into the applicator at the time of use. The use-life of the subject applicator is two years.
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