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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, Electric
510(k) Number K183515
Device Name MR8 Drill System, Midas Rex MR8 ClearView Tools
Applicant
Medtronic Powered Surgical Solutions
4620 N Beach St.
Fort Worth,  TX  76137
Applicant Contact Jenna Groves
Correspondent
Medtronic Powered Surgical Solutions
4620 N Beach St.
Fort Worth,  TX  76137
Correspondent Contact Jenna Groves
Regulation Number882.4360
Classification Product Code
HBC  
Subsequent Product Codes
ERL   HBB   HBE   HSZ  
Date Received12/18/2018
Decision Date 05/12/2019
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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