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

    EUTROCHAR

    K Number: K050957 · Decision May 18, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    840
    Registration Numbers
    840
    Same Product Code
    43
    Applicant Total
    2
    Review Days
    33

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    Basic Information

    Device Name
    EUTROCHAR
    K Number
    K050957
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Special Devices, Inc.
    Date Received
    April 15, 2005
    Decision Date
    May 18, 2005
    Product Code
    MDM
    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
    MDM Instrument, Manual, Surgical, General Use

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    Other Clearances by Special Devices, Inc.

    K Number Device Name
    K982354 SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M