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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Motor, Drill, Pneumatic
510(k) Number K962483
Device Name MIDAS REX III MOTOR
Applicant
Midas Rex Pneumatic Tools, Inc.
3001 Race St.
Fort Worth,  TX  76111
Applicant Contact MICHAEL FOWLER
Correspondent
Midas Rex Pneumatic Tools, Inc.
3001 Race St.
Fort Worth,  TX  76111
Correspondent Contact MICHAEL FOWLER
Regulation Number882.4370
Classification Product Code
HBB  
Date Received06/26/1996
Decision Date 11/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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