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

    MICRO-AIRE CEMENT REMOVAL TOOLS

    K Number: K880324 · Decision Feb 17, 1988
    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 CEMENT REMOVAL TOOLS
    K Number
    K880324
    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
    January 26, 1988
    Decision Date
    February 17, 1988
    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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