BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TACTYLON(TM) CONDOM

    K Number: K911431 · Decision Dec 27, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    7
    Review Days
    1365

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    Basic Information

    Device Name
    TACTYLON(TM) CONDOM
    K Number
    K911431
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Tactyl Technologies, Inc.
    Date Received
    April 2, 1991
    Decision Date
    December 27, 1994
    Product Code
    HIS
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HIS Condom

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    Other Clearances by Tactyl Technologies, Inc.

    K Number Device Name
    K955464 TACTYLON POWDER FREE EXAMINATION GLOVE
    K955419 POWDER FREE TACTYLON SURGEONS GLOVE
    K953583 LUBRICATED CONDOM
    K950185 TACTYLON(TM) POWDER FREE SURGEONS GLOVE
    K905109 PATIENT EXAMINATION GLOVE/HYPOALLERGENIC
    K902831 TACTYLON TM SURGICAL GLOVE