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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, photic, evoked response
510(k) Number K113785
Device Name ADHERENT VISUAL STIMULATOR GOGGLES
Original Applicant
ANSCHEL TECHNOLOGY, INC.
261 madison avenue, 24th floor
new york,  NY  10016
Original Contact glen park
Regulation Number882.1890
Classification Product Code
GWE  
Date Received12/23/2011
Decision Date 06/06/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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