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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 K200103
Device Name BIOTEQ Drainage Catheter Set (One Step Type)
Applicant
Bioteque Corporation
5f-6, # 23, Sec. 1, Chang’An E. Rd., Zhongshan Dist.
Taipei City,  TW 10441
Applicant Contact Stella Hsu
Correspondent
Bioteque Corporation
5f-6, # 23, Sec. 1, Chang’An E. Rd., Zhongshan Dist.
Taipei City,  TW 10441
Correspondent Contact Stella Hsu
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Code
GBO  
Date Received01/17/2020
Decision Date 10/09/2020
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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