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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Tissue Approximation Device
510(k) Number K211309
Device Name endomina system
Applicant
Endo Tools Therapeutics S.A.
Rue Auguste Piccard 48
Charleroi,  BE 6041
Applicant Contact Marine Rouyer
Correspondent
Endo Tools Therapeutics S.A.
Rue Auguste Piccard 48
Charleroi,  BE 6041
Correspondent Contact Marine Rouyer
Regulation Number876.1500
Classification Product Code
OCW  
Date Received04/30/2021
Decision Date 12/07/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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