The following data is part of a premarket notification filed by Taewoong Medical Co., Ltd with the FDA for Esophageal Tts Stent.
| Device ID | K211706 |
| 510k Number | K211706 |
| Device Name: | Esophageal TTS Stent |
| Classification | Prosthesis, Esophageal |
| Applicant | Taewoong Medical Co., Ltd 14 Gojeong-ro, Wolgot-myeon Gimpo-si, KR 10022 |
| Contact | Jennifer Moyer |
| Correspondent | Jennifer Moyer Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria, VA 22314 |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-03 |
| Decision Date | 2021-10-08 |