S-52 ELECTRONIC VIDEO LAPAROSCOPE

Laparoscope, General & Plastic Surgery

SOPRO

The following data is part of a premarket notification filed by Sopro with the FDA for S-52 Electronic Video Laparoscope.

Pre-market Notification Details

Device IDK973795
510k NumberK973795
Device Name:S-52 ELECTRONIC VIDEO LAPAROSCOPE
ClassificationLaparoscope, General & Plastic Surgery
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 CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-06
Decision Date1998-01-02
Summary:summary

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