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510(k) Data Aggregation

    K Number
    K961029
    Device Name
    KILTEX PROBE COVER
    Manufacturer
    KILTEX CORP.
    Date Cleared
    1996-07-25

    (133 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    KILTEX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Not Found
    Device Description
    natural latex prophylactics to be sold and used solely as ultrasound probe covers. These probe covers are identical to those formerly (prior to August 1992) manufactured by Carter-Wallace, Inc. for CIVCO Medical Instruments Co., Inc.
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