S-357 VIDEO IMAGING SYSTEM

Endoscopic Video Imaging System/component, Gastroenterology-urology

SOPRO

The following data is part of a premarket notification filed by Sopro with the FDA for S-357 Video Imaging System.

Pre-market Notification Details

Device IDK972540
510k NumberK972540
Device Name:S-357 VIDEO IMAGING SYSTEM
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
Applicant SOPRO PLACE ST. CHRISTOPHE LES ACCATES-LA VALENTINE Marseille,  FR 13011
ContactPierre Montillot
CorrespondentPierre Montillot
SOPRO PLACE ST. CHRISTOPHE LES ACCATES-LA VALENTINE Marseille,  FR 13011
Product CodeFET  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-07
Decision Date1997-09-18
Summary:summary

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