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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 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 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
Recalls CDRH Recalls
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