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

    MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR

    K Number: K862852 · Decision Aug 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    15
    Applicant Total
    40
    Review Days
    13

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    Basic Information

    Device Name
    MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR
    K Number
    K862852
    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
    July 29, 1986
    Decision Date
    August 11, 1986
    Product Code
    GFF
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GFF Bur, Surgical, General & Plastic Surgery

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    Other Clearances by Micro-Aire Surgical Instruments, Inc.

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    K903650 OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
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    K901967 DENDIA WERK BURS AND CUTTING DISCS
    K901735 ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444
    K902168 ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)
    K900033 MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS
    K900210 BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500
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