The following data is part of a premarket notification filed by Micro- Tech (nanjing) Co., Ltd. with the FDA for Polypectomy Snare.
| Device ID | K150316 |
| 510k Number | K150316 |
| Device Name: | Polypectomy Snare |
| Classification | Snare, Flexible |
| 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 | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-09 |
| Decision Date | 2015-07-30 |
| Summary: | summary |