The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Segmented Esophageal Stent System.
| Device ID | K182910 |
| 510k Number | K182910 |
| Device Name: | Segmented Esophageal Stent System |
| Classification | Prosthesis, Esophageal |
| Applicant | Micro-Tech (Nanjing) Co., Ltd. No. 10 Gaoke Third Road Nanjing, CN 210032 |
| Contact | Becky Li |
| Correspondent | Becky Li Micro-Tech (Nanjing) Co., Ltd. No. 10 Gaoke Third Road Nanjing, CN 210032 |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-17 |
| Decision Date | 2019-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932503580656 | K182910 | 000 |
| 06932503580526 | K182910 | 000 |
| 06932503580533 | K182910 | 000 |
| 06932503580540 | K182910 | 000 |
| 06932503580557 | K182910 | 000 |
| 06932503580564 | K182910 | 000 |
| 06932503580571 | K182910 | 000 |
| 06932503580588 | K182910 | 000 |
| 06932503580595 | K182910 | 000 |
| 06932503580601 | K182910 | 000 |
| 06932503580618 | K182910 | 000 |
| 06932503580625 | K182910 | 000 |
| 06932503580632 | K182910 | 000 |
| 06932503580649 | K182910 | 000 |
| 06932503580519 | K182910 | 000 |