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

    IM COLLAGEN SHIELD

    K Number: K896449 · Decision May 24, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    12
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    196

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    Basic Information

    Device Name
    IM COLLAGEN SHIELD
    K Number
    K896449
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4750
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Intermedical, Inc.
    Date Received
    November 9, 1989
    Decision Date
    May 24, 1990
    Product Code
    MOE
    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
    MOE Collagen Corneal Shield

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