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

    MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)

    K Number: K970965 · Decision Apr 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    90
    Applicant Total
    12
    Review Days
    23

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    Basic Information

    Device Name
    MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
    K Number
    K970965
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Midas Rex Pneumatic Tools, Inc.
    Date Received
    March 17, 1997
    Decision Date
    April 9, 1997
    Product Code
    ERL
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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    Other Clearances by Midas Rex Pneumatic Tools, Inc.

    K Number Device Name
    K972289 MIDAS REX MOTOR
    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)
    K900388 MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES
    K854462 MIDAS REX SURGICAL RUBBER DAM
    Search all 12 clearances from Midas Rex Pneumatic Tools, Inc. →