Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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, No. 23, Sec. 1, Chang’an E. Rd., Zhongshan Dist.
Taipei City,  TW 10441
Applicant Contact Stella Hsu
Correspondent
Bioteque Corporation
5F-6, No. 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
-
-