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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(k) Number K072315
Device Name MIDAS REX CURVED BUR
Applicant
Medtronic Powered Surgical Solutions
4620 N Beach St.
Fort Worth,  TX  76137
Applicant Contact JEFFREY HENDERSON
Correspondent
Medtronic Powered Surgical Solutions
4620 N Beach St.
Fort Worth,  TX  76137
Correspondent Contact JEFFREY HENDERSON
Regulation Number882.4310
Classification Product Code
HBE  
Subsequent Product Code
EQJ  
Date Received08/20/2007
Decision Date 09/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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