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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Nerve Locator
510(k) Number K142438
Device Name Nerve Monitoring Cable System
Applicant
Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.)
375 River Park Circle
Marquette,  MI  49855
Applicant Contact Sarah McIntyre
Correspondent
Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.)
375 River Park Circle
Marquette,  MI  49855
Correspondent Contact Sarah McIntyre
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Codes
ETN   GXZ  
Date Received08/29/2014
Decision Date 03/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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