Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches

Tubes, Gastrointestinal (and Accessories)

ProSys International Ltd

The following data is part of a premarket notification filed by Prosys International Ltd with the FDA for Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches.

Pre-market Notification Details

Device IDK193325
510k NumberK193325
Device Name:Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant ProSys International Ltd Suite 303, Highland House, 165 The Broadway Wimbledon,  GB Sw19 1ne
ContactGraham Steer
CorrespondentGraham Steer
ProSys International Ltd Suite 303, Highland House, 165 The Broadway Wimbledon,  GB Sw19 1ne
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-02
Decision Date2020-03-13

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