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

    POLY-OP (TM)

    K Number: K900759 · Decision May 24, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    97

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    Basic Information

    Device Name
    POLY-OP (TM)
    K Number
    K900759
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Nu-Gyn-Tek, Inc.
    Date Received
    February 16, 1990
    Decision Date
    May 24, 1990
    Product Code
    OCF
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OCF Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief

    Other Clearances by Nu-Gyn-Tek, Inc.

    K Number Device Name
    K862297 THE D & C PAD-SAC