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

    TMP MANDIBULAR COMPRESSION SYSTEM

    K Number: K905024 · Decision Jun 24, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    31
    Review Days
    229

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    Basic Information

    Device Name
    TMP MANDIBULAR COMPRESSION SYSTEM
    K Number
    K905024
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Techmedica, Inc.
    Date Received
    November 7, 1990
    Decision Date
    June 24, 1991
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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