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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Metal Clip For The Gi Tract
510(k) Number K183309
Device Name stentfix OTSC System Set
Applicant
Ovesco Endoscopy AG
Dorfackerstrasse 26
Tuebingen,  DE 72074
Applicant Contact Marc O. Schurr
Correspondent
Novineon Cro & Consulting, Ltd.
Dorfackerstrasse 26
Tuebingen,  DE 72074
Correspondent Contact Julia Ehmann
Regulation Number876.4400
Classification Product Code
PKL  
Subsequent Product Code
OCZ  
Date Received11/29/2018
Decision Date 10/22/2019
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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