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510(k) Data Aggregation

    K Number
    K092586
    Device Name
    MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU
    Manufacturer
    INNOLATEX (THAILAND) LIMITED
    Date Cleared
    2010-05-12

    (261 days)

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

    INNOLATEX (THAILAND) LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Innolatex condom used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
    Device Description
    Male Natural Rubber Latex Condom Straight side or Contoured or Flared in Shape, either Textured or Non-textured, Lubricated or Non-lubricated, Non-color or Colored and Flavored or Non-flavored
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