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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
Applicant
ANSCHEL TECHNOLOGY, INC.
261 madison avenue, 24th floor
new york,  NY  10016
Contact glen park
Regulation Number882.1890
Classification Product Code
GWE  
Date Received12/23/2011
Decision Date 06/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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