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

    STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY

    K Number: K931731 · Decision Aug 29, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    6
    Applicant Total
    101
    Review Days
    509

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    Basic Information

    Device Name
    STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY
    K Number
    K931731
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1290
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Storz Instrument Co.
    Date Received
    April 7, 1993
    Decision Date
    August 29, 1994
    Product Code
    HPL
    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
    HPL Device, Fixation, Ac-Powered, Ophthalmic

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