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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enteroscope and accessories
510(k) Number K191330
Device Name Arc Enterocuff
Applicant
Boddingtons Plastics Ltd
Wheelbarrow Park Estate, Pattenden Lane, Marden
Tonbridge,  GB TN12 9QJ
Applicant Contact Shimaa Elsawy
Correspondent
Boddingtons Plastics Ltd
Wheelbarrow Park Estate, Pattenden Lane, Marden
Tonbridge,  GB TN12 9QJ
Correspondent Contact Shimaa Elsawy
Regulation Number876.1500
Classification Product Code
FDA  
Date Received05/16/2019
Decision Date 01/31/2020
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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