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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name arthroscope
510(k) Number K082355
Device Name 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 Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
GWG  
Date Received08/15/2008
Decision Date 12/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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