The following data is part of a premarket notification filed by Leo Medical Co., Ltd. with the FDA for Ligation Device.
| Device ID | K172985 |
| 510k Number | K172985 |
| Device Name: | Ligation Device |
| Classification | Ligator, Hemorrhoidal |
| Applicant | Leo Medical Co., Ltd. 2 Floor, 10 Building 18 Huashan Road Changzhou, CN 213022 |
| Contact | Yunpeng Ma |
| Correspondent | Yunpeng Ma Leo Medical Co., Ltd. 2 Floor, 10 Building 18 Huashan Road Changzhou, CN 213022 |
| Product Code | FHN |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2018-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06923646508737 | K172985 | 000 |
| 06923646508652 | K172985 | 000 |
| 06923646508669 | K172985 | 000 |
| 06923646508676 | K172985 | 000 |
| 06923646508683 | K172985 | 000 |
| 06923646508690 | K172985 | 000 |
| 06923646508706 | K172985 | 000 |
| 06923646508713 | K172985 | 000 |
| 06923646508720 | K172985 | 000 |
| 06923646508744 | K172985 | 000 |
| 06923646508638 | K172985 | 000 |
| 06923646508645 | K172985 | 000 |