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

    TRACE MODEL #'S 840, 841, 842, 845

    K Number: K925145 · Decision May 19, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    218

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    Basic Information

    Device Name
    TRACE MODEL #'S 840, 841, 842, 845
    K Number
    K925145
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.3910
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trace Medical Equipment, Inc.
    Date Received
    October 13, 1992
    Decision Date
    May 19, 1993
    Product Code
    FYH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FYH Splint, Extremity, Noninflatable, External, Sterile

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    Other Clearances by Trace Medical Equipment, Inc.

    K Number Device Name
    K925502 TRACE MODEL# 840, 841,842 & 845 ARM BOARD