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

    Ace Medical Surgical Instruments

    K Number: K200387 · Decision Jul 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    154

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    Basic Information

    Device Name
    Ace Medical Surgical Instruments
    K Number
    K200387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4840
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ace Medical
    Date Received
    February 18, 2020
    Decision Date
    July 21, 2020
    Product Code
    HAE
    Advisory Committee
    Neurology
    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
    HAE Rongeur, Manual

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