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

    MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES

    K Number: K900388 · Decision May 7, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    64
    Applicant Total
    12
    Review Days
    98

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    Basic Information

    Device Name
    MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES
    K Number
    K900388
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Midas Rex Pneumatic Tools, Inc.
    Date Received
    January 29, 1990
    Decision Date
    May 7, 1990
    Product Code
    HBE
    Advisory Committee
    Neurology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

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    Other Clearances by Midas Rex Pneumatic Tools, Inc.

    K Number Device Name
    K972289 MIDAS REX MOTOR
    K970965 MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
    K962483 MIDAS REX III MOTOR
    K953434 MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)
    K954076 MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS
    K953433 MIDAS REX TELESCOPING SYSTEM
    K953432 ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS
    K952463 GS & GS20 SURGICAL TOOL SYSTEM
    K952300 MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS)
    K854462 MIDAS REX SURGICAL RUBBER DAM
    Search all 12 clearances from Midas Rex Pneumatic Tools, Inc. →