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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K020301
Device Name MODIFICATION TO VISTA STEREOSCOPE SYSTEM
Applicant
Vista Medical Technologies, Inc.
134 Flanders Rd.
Westborough,  MA  01581
Applicant Contact GRAHAM BAILLIE
Correspondent
Vista Medical Technologies, Inc.
134 Flanders Rd.
Westborough,  MA  01581
Correspondent Contact GRAHAM BAILLIE
Regulation Number876.1500
Classification Product Code
FET  
Date Received01/29/2002
Decision Date 02/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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