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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 K973798
Device Name S-357 VIDEO IMAGING SYSTEM
Applicant
SOPRO
PLACE ST. CHRISTOPHE
LES ACCATES-LA VALENTINE
MARSEILLE,  FR 13011
Applicant Contact PIERRE MONTILLOT
Correspondent
SOPRO
PLACE ST. CHRISTOPHE
LES ACCATES-LA VALENTINE
MARSEILLE,  FR 13011
Correspondent Contact PIERRE MONTILLOT
Regulation Number876.1500
Classification Product Code
FET  
Date Received10/06/1997
Decision Date 12/03/1997
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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