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

    AL-3300

    K Number: K940997 · Decision Sep 29, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    65
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    209

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    Basic Information

    Device Name
    AL-3300
    K Number
    K940997
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1425
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hoya Corp. USA
    Date Received
    March 4, 1994
    Decision Date
    September 29, 1994
    Product Code
    HLM
    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
    HLM Instrument, Measuring, Lens, Ac-Powered

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