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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 K090112
Device Name MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700
Applicant
Medtronic Powered Surgical Solutions
4620 N Beach St.
Fort Worth,  TX  76137
Applicant Contact JEFFERY HENDERSON
Correspondent
Medtronic Powered Surgical Solutions
4620 N Beach St.
Fort Worth,  TX  76137
Correspondent Contact JEFFERY HENDERSON
Regulation Number882.4370
Classification Product Code
HBB  
Date Received01/16/2009
Decision Date 03/26/2009
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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