The following data is part of a premarket notification filed by Taewoong Medical Co., Ltd with the FDA for Niti-s Stent & Introducer, Model Eoxxxx.
| Device ID | K041648 |
| 510k Number | K041648 |
| Device Name: | NITI-S STENT & INTRODUCER, MODEL EOXXXX |
| Classification | Prosthesis, Esophageal |
| Applicant | TAEWOONG MEDICAL CO., LTD 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | James Harvy Knauss |
| Correspondent | James Harvy Knauss TAEWOONG MEDICAL CO., LTD 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-17 |
| Decision Date | 2005-04-28 |
| Summary: | summary |