The following data is part of a premarket notification filed by Taewoong Medical Co., Ltd with the FDA for Niti-s Biliary Stent.
| Device ID | K073667 |
| 510k Number | K073667 |
| Device Name: | NITI-S BILIARY STENT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| 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 | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809233102114 | K073667 | 000 |
| 08809233100592 | K073667 | 000 |
| 08809233100585 | K073667 | 000 |
| 08809233100578 | K073667 | 000 |
| 08809233100561 | K073667 | 000 |
| 08809233100554 | K073667 | 000 |
| 08809233100547 | K073667 | 000 |
| 08809233100530 | K073667 | 000 |
| 08809233100509 | K073667 | 000 |
| 08809233100486 | K073667 | 000 |
| 08809233100479 | K073667 | 000 |
| 08809233100462 | K073667 | 000 |
| 08809233100455 | K073667 | 000 |
| 08809233100448 | K073667 | 000 |
| 08809233100431 | K073667 | 000 |
| 08809233100615 | K073667 | 000 |
| 08809233101926 | K073667 | 000 |
| 08809233102091 | K073667 | 000 |
| 08809233102084 | K073667 | 000 |
| 08809233102077 | K073667 | 000 |
| 08809233102060 | K073667 | 000 |
| 08809233102053 | K073667 | 000 |
| 08809233102046 | K073667 | 000 |
| 08809233102039 | K073667 | 000 |
| 08809233102008 | K073667 | 000 |
| 08809233101988 | K073667 | 000 |
| 08809233101971 | K073667 | 000 |
| 08809233101964 | K073667 | 000 |
| 08809233101957 | K073667 | 000 |
| 08809233101940 | K073667 | 000 |
| 08809233101933 | K073667 | 000 |
| 08809233100424 | K073667 | 000 |