S57D DIGITAL OPERATING ROOM CAMERA

Laparoscope, General & Plastic Surgery

SOPRO

The following data is part of a premarket notification filed by Sopro with the FDA for S57d Digital Operating Room Camera.

Pre-market Notification Details

Device IDK000422
510k NumberK000422
Device Name:S57D DIGITAL OPERATING ROOM CAMERA
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 Received2000-02-09
Decision Date2000-03-31

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