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510(k) Data Aggregation

    K Number
    K984488
    Device Name
    SHEER THIN
    Manufacturer
    TWE COMPANIES, INC.
    Date Cleared
    1999-02-01

    (46 days)

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

    TWE COMPANIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sheer Thin condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases.
    Device Description
    The condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight shafted, nipple end condom having a nominal width of 52 mm, nominal length of 180 mm and nominal thickness of 0.060 mm.
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