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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 K081102
Device Name VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM
Applicant
Visionsense, Ltd.
555 13th St. NW
Washington,  DC  20004
Applicant Contact GERARD J PRUD'HOMME
Correspondent
Visionsense, Ltd.
555 13th St. NW
Washington,  DC  20004
Correspondent Contact GERARD J PRUD'HOMME
Regulation Number882.1480
Classification Product Code
GWG  
Date Received04/17/2008
Decision Date 05/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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