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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 K163565
Device Name MR8 Drill System
Applicant
MEDTRONIC POWERED SURGICAL SOLUTIONS
4620 NORTH BEACH ST.
FORT WORTH,  TX  76137
Applicant Contact Deep Pal
Correspondent
MEDTRONIC NAVIGATION
826 COAL CREEK CIRCLE
LOUISVILLE,  CO  80027
Correspondent Contact John Connor
Regulation Number882.4360
Classification Product Code
HBC  
Subsequent Product Codes
ERL   HBB   HBE   HSZ  
Date Received12/19/2016
Decision Date 03/28/2017
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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