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510(k) Data Aggregation

    K Number
    K223883
    Device Name
    Daye Tampon
    Manufacturer
    Annes Daye Ltd
    Date Cleared
    2023-08-18

    (234 days)

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

    Annes Daye Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Daye Tampons are indicated for insertion into the vagina to absorb menstrual discharge.
    Device Description
    The Daye Tampons are unscented menstrual tampons consisting of an absorbent cotton pledget and a plastic (polyethylene) full-size applicator. The tampon pledget is made entirely of organic cotton, is fashioned with a W'wadding design and protective sleeve/overwrap. A withdrawal cord, made from mercerised organic cotton, is attached to the pledget. The Daye Tampons are available in regular (6-9 grams) and super (9-12 grams) absorbencies. The Daye Tampons and applicator are gamma irradiated in the finalpackaging. The Daye Tampons and applicators are repackaged together.
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