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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name image, illumination, fiberoptic, for endoscope
510(k) Number K970217
Device Name VISTA ILLUMINATION SYSTEM
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
FFS  
Subsequent Product Code
GCJ  
Date Received01/21/1997
Decision Date 04/02/1997
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
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