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

    UCA CREAM

    K Number: K792489 · Decision Feb 5, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    10
    Review Days
    64

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    Basic Information

    Device Name
    UCA CREAM
    K Number
    K792489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Vanaray Laboratories, Inc.
    Date Received
    December 3, 1979
    Decision Date
    February 5, 1980
    Product Code
    IYO
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IYO System, Imaging, Pulsed Echo, Ultrasonic

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    Other Clearances by Vanaray Laboratories, Inc.

    K Number Device Name
    K802647 ECA GEL PROUDUCT REFORMULATION
    K802648 UCA CREAM PRODUCT REFORMULATION
    K802649 UCA GEL PRODUCT REFORMAULATION
    K802650 UCA LOTION PRODUCT REFORMULATION
    K801383 ECA CREAM REFORMULATION
    K792490 UCA LOTION
    K792488 ECA GEL
    K792491 ECA CREAM
    K792492 UCA GEL