The following data is part of a premarket notification filed by Taewoong Medical Co., Ltd with the FDA for Niti-s Esophageal Stent.
| Device ID | K080782 |
| 510k Number | K080782 |
| Device Name: | NITI-S ESOPHAGEAL STENT |
| Classification | Prosthesis, Esophageal |
| Applicant | TAEWOONG MEDICAL CO., LTD 5536 TROWBRIDGE DRIVE Dunwoody, GA 30338 |
| Contact | Cathryn N Cambria |
| Correspondent | Cathryn N Cambria TAEWOONG MEDICAL CO., LTD 5536 TROWBRIDGE DRIVE Dunwoody, GA 30338 |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-19 |
| Decision Date | 2009-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809233103470 | K080782 | 000 |
| 08809233103289 | K080782 | 000 |
| 08809233103272 | K080782 | 000 |
| 08809233103265 | K080782 | 000 |
| 08809233103258 | K080782 | 000 |
| 08809233103234 | K080782 | 000 |
| 08809233103227 | K080782 | 000 |
| 08809233103210 | K080782 | 000 |
| 08809233103203 | K080782 | 000 |
| 08809233103197 | K080782 | 000 |
| 08809233103173 | K080782 | 000 |
| 08809233103166 | K080782 | 000 |
| 08809233103159 | K080782 | 000 |
| 08809233103142 | K080782 | 000 |
| 08809233103296 | K080782 | 000 |
| 08809233103319 | K080782 | 000 |
| 08809233103463 | K080782 | 000 |
| 08809233103456 | K080782 | 000 |
| 08809233103449 | K080782 | 000 |
| 08809233103432 | K080782 | 000 |
| 08809233103418 | K080782 | 000 |
| 08809233103401 | K080782 | 000 |
| 08809233103395 | K080782 | 000 |
| 08809233103388 | K080782 | 000 |
| 08809233103371 | K080782 | 000 |
| 08809233103357 | K080782 | 000 |
| 08809233103340 | K080782 | 000 |
| 08809233103333 | K080782 | 000 |
| 08809233103326 | K080782 | 000 |
| 08809233103135 | K080782 | 000 |