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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 K153548
FOIA Releasable 510(k) K153548
Device Name VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
Applicant
Visionsense, Ltd.
20 Hamagshimim St.
Petach Tikva, Hamerkaz,  IL 49348
Applicant Contact ALEX CHANIN
Correspondent
Licensale, Inc.
57 Lazy Brook Rd.
Monroe,  CT  06468
Correspondent Contact RAYMOND KELLY
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
GWG  
Date Received12/11/2015
Decision Date 02/22/2016
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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