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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic access overtube, gastroenterology-urology
510(k) Number K191067
Device Name Arc Endocuff Glide AEG110 & AEG120
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
FED  
Date Received04/22/2019
Decision Date 05/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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