The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd with the FDA for Single Use Multiclip Device.
| Device ID | K180325 |
| 510k Number | K180325 |
| Device Name: | Single Use MultiClip Device |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | Micro-Tech (Nanjing) CO., Ltd NO. 10 Gaoke Third Road Nanjing, CN |
| Contact | Becky Li |
| Correspondent | Becky Li Micro-Tech (Nanjing) CO., Ltd NO. 10 Gaoke Third Road Nanjing, CN |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-05 |
| Decision Date | 2018-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16932503534168 | K180325 | 000 |
| 16932503534069 | K180325 | 000 |
| 16932503534076 | K180325 | 000 |
| 16932503534083 | K180325 | 000 |
| 16932503534090 | K180325 | 000 |
| 16932503534106 | K180325 | 000 |
| 16932503534113 | K180325 | 000 |
| 16932503534120 | K180325 | 000 |
| 16932503534137 | K180325 | 000 |
| 16932503534144 | K180325 | 000 |
| 16932503534151 | K180325 | 000 |
| 16932503534052 | K180325 | 000 |