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

    MICROAIRE SMARTDRIVE SYSTEM

    K Number: K955591 · Decision Jan 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    387
    Registration Numbers
    387
    Same Product Code
    75
    Applicant Total
    4
    Review Days
    42

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    Basic Information

    Device Name
    MICROAIRE SMARTDRIVE SYSTEM
    K Number
    K955591
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microaire Surgical Instruments, Inc.
    Date Received
    December 7, 1995
    Decision Date
    January 18, 1996
    Product Code
    HWE
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

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