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

    MICRO-AIRE REPLACEMENT DRILL BURS

    K Number: K820281 · Decision Feb 23, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    15
    Applicant Total
    40
    Review Days
    21

    Basic Information

    Device Name
    MICRO-AIRE REPLACEMENT DRILL BURS
    K Number
    K820281
    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
    February 2, 1982
    Decision Date
    February 23, 1982
    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.

    K Number Device Name
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    K903713 OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229
    K903650 OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
    K903664 MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL
    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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