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

    UNKNOWN

    K Number: K828326 · Decision Mar 4, 1983
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    38

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    Basic Information

    Device Name
    UNKNOWN
    K Number
    K828326
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Lasertek OY
    Date Received
    January 25, 1983
    Decision Date
    March 4, 1983
    Advisory Committee
    Unknown
    Review Advisory Committee
    RA
    Third Party
    N

    Other Clearances by Lasertek OY

    K Number Device Name
    K832089 MODEL 150K LASER COAGULATOR
    K781965 LASER COAGULATOR, MODEL 41AK
    K782106 COAGULATOR, MODEL 40 AARGON