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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 K101734
FOIA Releasable 510(k) K101734
Device Name VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES
Applicant
Visionscope Technologies, LLC
2352 Main St.
Suite 303
Concord,  MA  01742
Applicant Contact LIM CHEUNG PH.D
Correspondent
Visionscope Technologies, LLC
2352 Main St.
Suite 303
Concord,  MA  01742
Correspondent Contact LIM CHEUNG PH.D
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
GCJ  
Date Received06/21/2010
Decision Date 09/08/2010
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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