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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Tubes With Enteral Specific Connectors
510(k) Number K203633
Device Name Enteral Extension Sets
Applicant
GBUK Group, Ltd.
Blackwood Hall Business Park, N. Duffield
Selby,  GB YO85DD
Applicant Contact Lucy Islip
Correspondent
GBUK Group, Ltd.
Blackwood Hall Business Park, N. Duffield
Selby,  GB YO85DD
Correspondent Contact Chloe Kelly
Regulation Number876.5980
Classification Product Code
PIF  
Date Received12/11/2020
Decision Date 08/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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