The following data is part of a premarket notification filed by Bioteque Corporation with the FDA for Bioteq Drainage Catheter Set (one Step Type).
|Device Name:||BIOTEQ Drainage Catheter Set (One Step Type)|
|Classification||Stents, Drains And Dilators For The Biliary Ducts|
|Applicant||Bioteque Corporation 5F-6, No. 23, Sec. 1, Chang’an E. Rd., Zhongshan Dist. Taipei City, TW 10441|
Bioteque Corporation 5F-6, No. 23, Sec. 1, Chang’an E. Rd., Zhongshan Dist. Taipei City, TW 10441
|CFR Regulation Number||876.5010 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|