Nutricare Clear-ISOSAF Nasogastric Feeding Tube

Gastrointestinal Tubes With Enteral Specific Connectors

Three Circles Consulting Limited

The following data is part of a premarket notification filed by Three Circles Consulting Limited with the FDA for Nutricare Clear-isosaf Nasogastric Feeding Tube.

Pre-market Notification Details

Device IDK202357
510k NumberK202357
Device Name:Nutricare Clear-ISOSAF Nasogastric Feeding Tube
ClassificationGastrointestinal Tubes With Enteral Specific Connectors
Applicant Three Circles Consulting Limited MED IC4, Keele University Science & Innovation Park Keele,  GB St5 5nl
ContactMatthew Theobald
CorrespondentMatthew Theobald
GBUK Group Limited Blackwood Hall Business Park, North Duffield Selby,  GB Y08 5dd
Product CodePIF  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-19
Decision Date2020-10-01

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