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 ID | K200103 |
| 510k Number | K200103 |
| 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 |
| Contact | Stella Hsu |
| Correspondent | Stella Hsu Bioteque Corporation 5F-6, No. 23, Sec. 1, Chang’an E. Rd., Zhongshan Dist. Taipei City, TW 10441 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-17 |
| Decision Date | 2020-10-09 |