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

    MODEL 668, TRACTION SPLINT, ADULT

    K Number: K864765 · Decision Dec 17, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    205
    Registration Numbers
    205
    Same Product Code
    37
    Applicant Total
    5
    Review Days
    12

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    Basic Information

    Device Name
    MODEL 668, TRACTION SPLINT, ADULT
    K Number
    K864765
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.5850
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Ferno-Washington, Inc.
    Date Received
    December 5, 1986
    Decision Date
    December 17, 1986
    Product Code
    HST
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HST Apparatus, Traction, Non-Powered

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