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

    REFRACTEC MCS-100

    K Number: K980522 · Decision Jul 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    162

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    Basic Information

    Device Name
    REFRACTEC MCS-100
    K Number
    K980522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4100
    Medical Specialty
    Ophthalmic
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Refractec, Inc.
    Date Received
    February 10, 1998
    Decision Date
    July 22, 1998
    Product Code
    HQR
    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
    HQR Apparatus, Cautery, Radiofrequency, Ac-Powered

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    Other Clearances by Refractec, Inc.

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