The following data is part of a premarket notification filed by Taewoong Medical Co., Ltd with the FDA for Esophageal Tts Stent.
| Device ID | K123205 |
| 510k Number | K123205 |
| Device Name: | ESOPHAGEAL TTS STENT |
| Classification | Prosthesis, Esophageal |
| Applicant | TAEWOONG MEDICAL CO., LTD 13417 QUIVAS ST Westminster, CO 80234 |
| Contact | Calley Herzog |
| Correspondent | Calley Herzog TAEWOONG MEDICAL CO., LTD 13417 QUIVAS ST Westminster, CO 80234 |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-12 |
| Decision Date | 2013-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809293833171 | K123205 | 000 |
| 08809293832389 | K123205 | 000 |
| 08809293832396 | K123205 | 000 |
| 08809293832471 | K123205 | 000 |
| 08809293832495 | K123205 | 000 |
| 08809293833010 | K123205 | 000 |
| 08809293833126 | K123205 | 000 |
| 08809293833133 | K123205 | 000 |
| 08809293833140 | K123205 | 000 |
| 08809293833157 | K123205 | 000 |
| 08809293833164 | K123205 | 000 |
| 08809293832365 | K123205 | 000 |