The following data is part of a premarket notification filed by Micro-tech (nanjing) Co.,ltd. with the FDA for Sterile Repositionable Hemostasis Clipping Device.
| Device ID | K152001 |
| 510k Number | K152001 |
| Device Name: | Sterile Repositionable Hemostasis Clipping Device |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| 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 | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-20 |
| Decision Date | 2015-12-10 |
| Summary: | summary |