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

    COLLAGEN SHIELD FOR ACUTE CARE

    K Number: K913148 · Decision Oct 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    12
    Same Product Code
    18
    Applicant Total
    13
    Review Days
    91

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    Basic Information

    Device Name
    COLLAGEN SHIELD FOR ACUTE CARE
    K Number
    K913148
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4750
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitaphore Corp.
    Date Received
    July 16, 1991
    Decision Date
    October 15, 1991
    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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