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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 K202357
Device Name Nutricare Clear-ISOSAF Nasogastric Feeding Tube
Applicant
Three Circles Consulting Limited
MED IC4, Keele University Science & Innovation Park
Keele,  GB ST5 5NL
Applicant Contact Matthew Theobald
Correspondent
GBUK Group Limited
Blackwood Hall Business Park, North Duffield
Selby,  GB Y08 5DD
Correspondent Contact Matthew Theobald
Regulation Number876.5980
Classification Product Code
PIF  
Date Received08/19/2020
Decision Date 10/01/2020
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
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