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

    ATL 225 MW TRAIL LENS SET

    K Number: K852548 · Decision Jul 31, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    49

    Basic Information

    Device Name
    ATL 225 MW TRAIL LENS SET
    K Number
    K852548
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1415
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    ASCON MEDICAL INSTRUMENTS, LTD.
    Date Received
    June 12, 1985
    Decision Date
    July 31, 1985
    Product Code
    HPA
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HPA Frame, Trial, Ophthalmic

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