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

    TACTYLON CONDOM

    K Number: K971590 · Decision Oct 7, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    21
    Applicant Total
    2
    Review Days
    159

    Basic Information

    Device Name
    TACTYLON CONDOM
    K Number
    K971590
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SENSICON CORP.
    Date Received
    May 1, 1997
    Decision Date
    October 7, 1997
    Product Code
    MOL
    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
    MOL Condom, Synthetic

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    Other Clearances by SENSICON CORP.

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