The following data is part of a premarket notification filed by Anrei Medical (hangzhou) Co., Ltd. with the FDA for Single Use Rotatable And Repositionable Hemoclip.
| Device ID | K201771 |
| 510k Number | K201771 |
| Device Name: | Single Use Rotatable And Repositionable Hemoclip |
| Classification | Hemostatic Metal Clip For The Gi Tract |
| Applicant | Anrei Medical (Hangzhou) Co., Ltd. No.3 Ave. 8, Hangzhou Economic Development Area Hangzhou, CN 310018 |
| Contact | Huibing Yang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | PKL |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-29 |
| Decision Date | 2020-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06948318912346 | K201771 | 000 |
| 06948318912339 | K201771 | 000 |
| 06948318912322 | K201771 | 000 |
| 06948318912315 | K201771 | 000 |
| 06948318912308 | K201771 | 000 |
| 06948318912292 | K201771 | 000 |
| 06948318912285 | K201771 | 000 |
| 06948318912278 | K201771 | 000 |