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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 K121931
Device Name NONDISPOSABLE STIMULATING INSTRUMENTS
Original Applicant
NEUROVISION MEDICAL PRODUCTS, INC.
2225 sperry ave, suite 1000
ventura,  CA  93003
Original Contact christine vergely
Regulation Number874.1820
Classification Product Code
ETN  
Date Received07/09/2012
Decision Date 10/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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