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

    LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD

    K Number: K884362 · Decision Nov 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    40

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    Basic Information

    Device Name
    LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD
    K Number
    K884362
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.3300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Bausch & Lomb Pharmaceutical, Inc.
    Date Received
    October 20, 1988
    Decision Date
    November 29, 1988
    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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    Other Clearances by Bausch & Lomb Pharmaceutical, Inc.

    K Number Device Name
    K884962 ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA
    K884960 ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL
    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