BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

    SURGICAL HANDPIECES, MIKRO SAW HANDPIECES

    K Number: K080939 · Decision Jul 29, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    8
    Applicant Total
    18
    Review Days
    117

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    Basic Information

    Device Name
    SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
    K Number
    K080939
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W&H Dentalwerk Buermoos GmbH
    Date Received
    April 3, 2008
    Decision Date
    July 29, 2008
    Product Code
    KMW
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KMW Handpiece, Rotary Bone Cutting

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