DEX Device

Laparoscope, General & Plastic Surgery

Dex Surgical

The following data is part of a premarket notification filed by Dex Surgical with the FDA for Dex Device.

Pre-market Notification Details

Device IDK191878
510k NumberK191878
Device Name:DEX Device
ClassificationLaparoscope, General & Plastic Surgery
Applicant Dex Surgical 3 Rue Des Petits Ruisseaux Verrieres Le Buisson,  FR 91370
ContactGuillaume Noury
CorrespondentGuillaume Noury
Dex Surgical 3 Rue Des Petits Ruisseaux Verrieres Le Buisson,  FR 91370
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-15
Decision Date2021-01-29

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