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

    KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400

    K Number: K980508 · Decision May 1, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    82
    Applicant Total
    4
    Review Days
    80

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    Basic Information

    Device Name
    KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400
    K Number
    K980508
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4370
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro Specialties, Inc.
    Date Received
    February 10, 1998
    Decision Date
    May 1, 1998
    Product Code
    HNO
    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
    HNO Keratome, Ac-Powered

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    Other Clearances by Micro Specialties, Inc.

    K Number Device Name
    K033457 M2 COMPATIBLE MICROKERATOME BLADE
    K020482 KERATOME BLADE 200200 & 600600
    K980510 KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)