The following data is part of a premarket notification filed by Lepu Medical Technology (beijing) Co., Ltd with the FDA for Radial Artery Compression Tourniquet.
| Device ID | K111837 |
| 510k Number | K111837 |
| Device Name: | RADIAL ARTERY COMPRESSION TOURNIQUET |
| Classification | Clamp, Vascular |
| Applicant | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD NO. 37 CHAOQIAN ROAD Beijing, Changping District, CN 102200 |
| Contact | Shan Zhao |
| Correspondent | Shan Zhao LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD NO. 37 CHAOQIAN ROAD Beijing, Changping District, CN 102200 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-29 |
| Decision Date | 2011-09-27 |
| Summary: | summary |