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

    BIO-COR COLLAGEN CORNEAL SHIELD

    K Number: K944872 · Decision Jul 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    12
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    296

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    Basic Information

    Device Name
    BIO-COR COLLAGEN CORNEAL SHIELD
    K Number
    K944872
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4750
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bausch & Lomb Healthcare and Optics Worldwide
    Date Received
    October 3, 1994
    Decision Date
    July 26, 1995
    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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