BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM

    K Number: K973268 · Decision Nov 26, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    4
    Review Days
    89

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    Basic Information

    Device Name
    MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM
    K Number
    K973268
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microaire Surgical Instruments, Inc.
    Date Received
    August 29, 1997
    Decision Date
    November 26, 1997
    Product Code
    BTA
    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
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Microaire Surgical Instruments, Inc.

    K Number Device Name
    K014060 MICROAIRE 1000E SYSTEM
    K981922 LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI
    K955591 MICROAIRE SMARTDRIVE SYSTEM