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

    IMPOWER EXTERNAL VACUUM SYSTEM

    K Number: K980291 · Decision Mar 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    86
    Applicant Total
    7
    Review Days
    44

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    Basic Information

    Device Name
    IMPOWER EXTERNAL VACUUM SYSTEM
    K Number
    K980291
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5020
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imagyn Medical Technologies, Inc.
    Date Received
    January 26, 1998
    Decision Date
    March 11, 1998
    Product Code
    LKY
    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
    LKY Device, External Penile Rigidity

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