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

    ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL

    K Number: K884960 · Decision Feb 13, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    12
    Same Product Code
    18
    Applicant Total
    6
    Review Days
    87

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    Basic Information

    Device Name
    ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL
    K Number
    K884960
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4750
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Bausch & Lomb Pharmaceutical, Inc.
    Date Received
    November 18, 1988
    Decision Date
    February 13, 1989
    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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    Other Clearances by Bausch & Lomb Pharmaceutical, Inc.

    K Number Device Name
    K884962 ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA
    K884961 ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL
    K884363 LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL
    K884364 LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL
    K884362 LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD