The following data is part of a premarket notification filed by Wuxi Yushou Medical Applicances Co., Ltd with the FDA for Disposable High Pressure Injector Syringe.
| Device ID | K152906 |
| 510k Number | K152906 |
| Device Name: | Disposable High Pressure Injector Syringe |
| Classification | Injector And Syringe, Angiographic |
| Applicant | WUXI YUSHOU MEDICAL APPLICANCES CO., LTD NO. 215 XIGANG ROAD, DONGBEITANG Wuxi, CN 214191 |
| Contact | Wu Feng |
| Correspondent | Jung Peng P&L Scientific 6840 SW 45th LN Unit 5 Miami, FL 33155 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-01 |
| Decision Date | 2016-11-22 |
| Summary: | summary |