Enteral Extension Sets

Gastrointestinal Tubes With Enteral Specific Connectors

GBUK Group Ltd

The following data is part of a premarket notification filed by Gbuk Group Ltd with the FDA for Enteral Extension Sets.

Pre-market Notification Details

Device IDK203633
510k NumberK203633
Device Name:Enteral Extension Sets
ClassificationGastrointestinal Tubes With Enteral Specific Connectors
Applicant GBUK Group Ltd Blackwood Hall Business Park, North Duffield Selby,  GB Yo85dd
ContactLucy Islip
CorrespondentChloe Kelly
GBUK Group Ltd Blackwood Hall Business Park, North Duffield Selby,  GB Yo85dd
Product CodePIF  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-11
Decision Date2021-08-19

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