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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 K201744
Device Name Su2ura Approximation Device
Applicant
Anchora Medical, Ltd.
Beit Tavor, Entrance 2, 3rd Floor
I.Z. Yokneam,  IL 2069202
Applicant Contact Yoni Epstein
Correspondent
Duet-Medical Consulting, Ltd.
10 Haanafa St. Pob536
Zur Moshe,  IL 42810
Correspondent Contact Eilat Ezra
Regulation Number876.1500
Classification Product Code
OCW  
Date Received06/25/2020
Decision Date 06/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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