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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K241801
Device Name Tornus ES
Applicant
Asahi Intecc Co., Ltd.
3-100 Akatsuki-Cho
Seto-Shi,  JP 489-0071
Applicant Contact Katsuhiko Fujimura
Correspondent
Cardiomed Device Consultants
1783 Forest Dr.
Suite 254
Annappolis,  MD  21401
Correspondent Contact Candace Cederman
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/21/2024
Decision Date 12/17/2024
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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