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

    TITAN AIR SPECTACLE FRAME

    K Number: K896350 · Decision Dec 18, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    42

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    Basic Information

    Device Name
    TITAN AIR SPECTACLE FRAME
    K Number
    K896350
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Acces Intl. Eyewear
    Date Received
    November 6, 1989
    Decision Date
    December 18, 1989
    Product Code
    HQJ
    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
    HQJ Implant, Absorbable, (Scleral Buckling Methods)

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