The following data is part of a premarket notification filed by Micro-tech (nanjing) Co.,ltd. with the FDA for Esophageal Stent System.
| Device ID | K172813 |
| 510k Number | K172813 |
| Device Name: | 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 | 2017-09-18 |
| Decision Date | 2018-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932503580366 | K172813 | 000 |
| 06932503580175 | K172813 | 000 |
| 06932503580168 | K172813 | 000 |
| 06932503580151 | K172813 | 000 |
| 06932503580144 | K172813 | 000 |
| 06932503580137 | K172813 | 000 |
| 06932503580120 | K172813 | 000 |
| 06932503580113 | K172813 | 000 |
| 06932503580106 | K172813 | 000 |
| 06932503580090 | K172813 | 000 |
| 06932503580083 | K172813 | 000 |
| 06932503580076 | K172813 | 000 |
| 06932503580069 | K172813 | 000 |
| 06932503580052 | K172813 | 000 |
| 06932503580045 | K172813 | 000 |
| 06932503580038 | K172813 | 000 |
| 06932503580021 | K172813 | 000 |
| 06932503580182 | K172813 | 000 |
| 06932503580199 | K172813 | 000 |
| 06932503580359 | K172813 | 000 |
| 06932503580342 | K172813 | 000 |
| 06932503580335 | K172813 | 000 |
| 06932503580328 | K172813 | 000 |
| 06932503580311 | K172813 | 000 |
| 06932503580304 | K172813 | 000 |
| 06932503580298 | K172813 | 000 |
| 06932503580281 | K172813 | 000 |
| 06932503580274 | K172813 | 000 |
| 06932503580267 | K172813 | 000 |
| 06932503580250 | K172813 | 000 |
| 06932503580243 | K172813 | 000 |
| 06932503580236 | K172813 | 000 |
| 06932503580229 | K172813 | 000 |
| 06932503580212 | K172813 | 000 |
| 06932503580205 | K172813 | 000 |
| 06932503580014 | K172813 | 000 |