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

    BENDEREV DRILL GUIDE

    K Number: K923776 · Decision Nov 6, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    101

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    Basic Information

    Device Name
    BENDEREV DRILL GUIDE
    K Number
    K923776
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neimark Labs, Inc.
    Date Received
    July 28, 1992
    Decision Date
    November 6, 1992
    Product Code
    HXY
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HXY Brace, Drill

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