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510(k) Data Aggregation

    K Number
    K041717
    Device Name
    POWERSTICK MALE LATEX CONDOMS
    Manufacturer
    A.P.DEAUVILLE, LLC.
    Date Cleared
    2005-01-13

    (203 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.P.DEAUVILLE, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Power Stick Male Latex Condom is used for controptive fic fower belen cric purposes (to help prevent pregnancy and for prophylaction of sexually transmitted diseases).
    Device Description
    This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. These two types of condoms, ribbed and dotted-ribbed, are at a nominal length of 170mm., a nominal width of 52 mm (±2mm) and are at a nominal thickness of .06 mm (±.02 mm).
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