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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscope, neurological
510(k) Number K131434
FOIA Releasable 510(k) K131434
Device Name VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
Applicant
VISIONSENSE, LTD.
555 13TH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact GERARD J PRUD'HOMME
Correspondent
VISIONSENSE, LTD.
555 13TH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact GERARD J PRUD'HOMME
Regulation Number882.1480
Classification Product Code
GWG  
Date Received05/17/2013
Decision Date 07/16/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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