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510(k) Data Aggregation

    K Number
    K211519
    Device Name
    Every Cycle Reusable Tampon Applicator
    Manufacturer
    Cycle, LLC
    Date Cleared
    2021-08-13

    (88 days)

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

    Cycle, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Every Cycle™ Reusable Tampon Applicator is intended to be used to insert a digital menstrual tampon into the vagina.
    Device Description
    The Every Cycle™ 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 load the applicator with a legally-marketed digital/non-applicator menstrual tampon. The use-life of the subject device is two years. The applicator is comprised of a barrel with a slit, plunger, large (outer) cap, storage compartment, and a small cap.
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