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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 K223254
Device Name C2 Xplore
Applicant
Inomed Medizintechnik GmbH
Im Hausgruen 29
Emmendingen,  DE 79312
Applicant Contact Maximilian Wimmer
Correspondent
Inomed Medizintechnik GmbH
Im Hausgruen 29
Emmendingen,  DE 79312
Correspondent Contact Anja Riesterer
Regulation Number874.1820
Classification Product Code
ETN  
Subsequent Product Code
GWF  
Date Received10/21/2022
Decision Date 01/27/2023
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
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