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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 K110138
Device Name PAIRED HYDROGEL ELECTRODE
Applicant
NEUROVISION MEDICAL PRODUCTS, INC.
2225 SPERRY AVE, SUITE 1000
VENTURA,  CA  93003
Applicant Contact CHRISTINE VERGELY
Correspondent
NEUROVISION MEDICAL PRODUCTS, INC.
2225 SPERRY AVE, SUITE 1000
VENTURA,  CA  93003
Correspondent Contact CHRISTINE VERGELY
Regulation Number874.1820
Classification Product Code
ETN  
Date Received01/18/2011
Decision Date 04/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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