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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 K170312
Device Name IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools
Applicant
Medtronic Powered Surgical Solutions
4620 N Beach St.
Fort Worth,  TX  76137
Applicant Contact DEEP PAL
Correspondent
Medtronic Neurosurgery
125 Cremona Dr.
Goleta,  CA  93117
Correspondent Contact XIAOJIAN SUN
Regulation Number882.4360
Classification Product Code
HBC  
Subsequent Product Codes
EQJ   ERL   HBE   HRX   HWE  
KFK  
Date Received02/01/2017
Decision Date 05/15/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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