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

    TECHMEDICA DRILL GUIDE

    K Number: K841297 · Decision Apr 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    526
    Registration Numbers
    526
    Same Product Code
    18
    Applicant Total
    31
    Review Days
    26

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    Basic Information

    Device Name
    TECHMEDICA DRILL GUIDE
    K Number
    K841297
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Techmedica, Inc.
    Date Received
    March 30, 1984
    Decision Date
    April 25, 1984
    Product Code
    FZX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FZX Guide, Surgical, Instrument

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