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

    MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER

    K Number: K851443 · Decision May 3, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    55
    Applicant Total
    40
    Review Days
    22

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    Basic Information

    Device Name
    MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER
    K Number
    K851443
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Micro-Aire Surgical Instruments, Inc.
    Date Received
    April 11, 1985
    Decision Date
    May 3, 1985
    Product Code
    HSZ
    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
    HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

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    Other Clearances by Micro-Aire Surgical Instruments, Inc.

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    K902676 MICROGUARD, ORTHOPEDIC PIN PROTECTORS
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    K901967 DENDIA WERK BURS AND CUTTING DISCS
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    K902168 ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)
    K900033 MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS
    K900210 BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500
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