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510(k) Data Aggregation

    K Number
    K140077
    Device Name
    ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED
    Manufacturer
    ALBAAD LTD.
    Date Cleared
    2014-09-22

    (252 days)

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

    ALBAAD LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Albaad Plastic Applicator Tampons, Available in regularand super absorbency are inserted into the vagina and used to absorb menstrual or other vaginal discharge.
    Device Description
    The Albaad Tampons are unscented Plastic Applicator tampons. The Applicator Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge. These tampons applicator types, will be marketed in 2 absorbencies: regular (6-9g) and super, (9-12g) These Tampons are made from 100% viscose, and a 100% cotton cord. The applicators are low density and high density polyethylene.
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