BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)

    K Number: K971992 · Decision Aug 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    10
    Applicant Total
    10
    Review Days
    64

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    Basic Information

    Device Name
    UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)
    K Number
    K971992
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5160
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Uromed Corp.
    Date Received
    May 29, 1997
    Decision Date
    August 1, 1997
    Product Code
    FHA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FHA Clamp, Penile

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