BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OPERATING MICROSCOPE AA OM 10

    K Number: K941399 · Decision Apr 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    31

    Basic Information

    Device Name
    OPERATING MICROSCOPE AA OM 10
    K Number
    K941399
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4700
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    APPASAMY ASSOCIATES (U.S.A.), INC.
    Date Received
    March 22, 1994
    Decision Date
    April 22, 1994
    Product Code
    FSO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FSO Microscope, Surgical, General & Plastic Surgery

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