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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 K971373
Device Name VISTA SINGLE CHIP VIDEO CAMERA
Applicant
VISTA MEDICAL TECHNOLOGIES, INC.
134 FLANDERS RD.
WESTBOROUGH,  MA  01581
Applicant Contact MARTIN NEWMAN
Correspondent
VISTA MEDICAL TECHNOLOGIES, INC.
134 FLANDERS RD.
WESTBOROUGH,  MA  01581
Correspondent Contact MARTIN NEWMAN
Regulation Number876.1500
Classification Product Code
FET  
Date Received04/14/1997
Decision Date 05/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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