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

    CASSETTE SYSTEM FOR STORZ

    K Number: K942945 · Decision Dec 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    311
    Applicant Total
    23
    Review Days
    166

    Basic Information

    Device Name
    CASSETTE SYSTEM FOR STORZ
    K Number
    K942945
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    SURGIN SURGICAL INSTRUMENTATION, INC.
    Date Received
    June 22, 1994
    Decision Date
    December 5, 1994
    Product Code
    HQC
    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
    HQC Unit, Phacofragmentation

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