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

    OMNI PHASE PENILE PROSTHESIS

    K Number: K850019 · Decision Apr 9, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    31
    Applicant Total
    20
    Review Days
    96

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    Basic Information

    Device Name
    OMNI PHASE PENILE PROSTHESIS
    K Number
    K850019
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.3630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Dacomed Corp.
    Date Received
    January 3, 1985
    Decision Date
    April 9, 1985
    Product Code
    FAE
    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
    FAE Prosthesis, Penile

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