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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 K972289
Device Name MIDAS REX MOTOR
Applicant
MIDAS REX PNEUMATIC TOOLS, INC.
3001 RACE ST.
FORT WORTH,  TX  76111 -4117
Applicant Contact MICHAEL FOWLER
Correspondent
MIDAS REX PNEUMATIC TOOLS, INC.
3001 RACE ST.
FORT WORTH,  TX  76111 -4117
Correspondent Contact MICHAEL FOWLER
Regulation Number882.4370
Classification Product Code
HBB  
Date Received06/19/1997
Decision Date 09/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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