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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 K230853
Device Name EARP Nerve Cuff Electrode
Applicant
Nvision Biomedical Technologies, Inc.
4590 Lockhill Selma
San Antonio,  TX  78249
Applicant Contact Diana Langham
Correspondent
Watershed Idea Foundry
1815 Aston Ave., Suite 106
Carlsbad,  CA  92008
Correspondent Contact Jeffrey Brittan
Regulation Number874.1820
Classification Product Code
ETN  
Date Received03/28/2023
Decision Date 10/06/2023
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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