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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K152505
Device Name C2 NerveMonitor System
Applicant
INOMED MEDIZINTECHNIK GMBH
IM HAUSGRUEN 29
EMMENDINGEN BADEN- WUERTTEMBERG,  DE D- 79312
Applicant Contact SASCHKA BUSCH
Correspondent
INOMED MEDIZINTECHNIK GMBH
IM HAUSGRUEN 29
EMMENDINGEN BADEN- WUERTTEMBERG,  DE D- 79312
Correspondent Contact SASCHKA BUSCH
Regulation Number874.1820
Classification Product Code
ETN  
Date Received09/02/2015
Decision Date 02/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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