The following data is part of a premarket notification filed by Taewoong Medical Co., Ltd with the FDA for Esophageal Tts Stent.
| Device ID | K113551 |
| 510k Number | K113551 |
| Device Name: | ESOPHAGEAL TTS STENT |
| Classification | Prosthesis, Esophageal |
| Applicant | TAEWOONG MEDICAL CO., LTD 400 N. WASHINGTON ST SUITE 100 Alexandria, VA 22314 |
| Contact | Stephen Rhodes |
| Correspondent | Stephen Rhodes TAEWOONG MEDICAL CO., LTD 400 N. WASHINGTON ST SUITE 100 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 | 2011-12-01 |
| Decision Date | 2012-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809293833058 | K113551 | 000 |
| 08809234330424 | K113551 | 000 |
| 08809234330431 | K113551 | 000 |
| 08809293830309 | K113551 | 000 |
| 08809293830316 | K113551 | 000 |
| 08809293830323 | K113551 | 000 |
| 08809293830330 | K113551 | 000 |
| 08809293830347 | K113551 | 000 |
| 08809293830354 | K113551 | 000 |
| 08809293833034 | K113551 | 000 |
| 08809293833041 | K113551 | 000 |
| 08809234330417 | K113551 | 000 |