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

    EASYDRILL AUTOSTOP CRANIAL PERFORATOR

    K Number: K141455 · Decision Mar 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    287

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    Basic Information

    Device Name
    EASYDRILL AUTOSTOP CRANIAL PERFORATOR
    K Number
    K141455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4305
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micromar Ind. Com. , Ltd.
    Date Received
    June 2, 2014
    Decision Date
    March 16, 2015
    Product Code
    HBF
    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
    HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)

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