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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 K141002
Device Name VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
Applicant
Visionsense, Ltd.
57 Lazy Brook Rd.
Monroe,  CT  06468
Applicant Contact RAYMOND KELLY
Correspondent
Visionsense, Ltd.
57 Lazy Brook Rd.
Monroe,  CT  06468
Correspondent Contact RAYMOND KELLY
Regulation Number888.1100
Classification Product Code
HRX  
Date Received04/18/2014
Decision Date 06/26/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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