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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteral Specific Transition Connectors
510(k) Number K220165
Device Name Enteral Transition Adaptor
Applicant
GBUK Group, Ltd.
Blackwood Hall Business Park, N. Duffield
Selby,  GB YO85DD
Applicant Contact Rachael Hume
Correspondent
GBUK Group, Ltd.
Blackwood Hall Business Park, N. Duffield
Selby,  GB YO85DD
Correspondent Contact Rachael Hume
Regulation Number876.5980
Classification Product Code
PIO  
Date Received01/20/2022
Decision Date 10/21/2022
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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