The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Disposable Dual Action Tissue Clip.
| Device ID | K212748 |
| 510k Number | K212748 |
| Device Name: | Disposable Dual Action Tissue Clip |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Developement Zone Nanjing, CN 210032 |
| Contact | Cecilia Sun |
| Correspondent | Cecilia Sun Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Developement Zone 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 | 2021-08-30 |
| Decision Date | 2022-01-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932503535564 | K212748 | 000 |
| 06932503535557 | K212748 | 000 |
| 16932503535547 | K212748 | 000 |
| 16932503535530 | K212748 | 000 |
| 16932503535523 | K212748 | 000 |
| 16932503535516 | K212748 | 000 |