The following data is part of a premarket notification filed by Sunny Medical Device (shenzhen) Co.,ltd. with the FDA for Sunmed Control Syringes.
| Device ID | K160190 |
| 510k Number | K160190 |
| Device Name: | Sunmed Control Syringes |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Sunny Medical Device (Shenzhen) Co.,Ltd. 56 Lehigh Aisle Irvine, CA 92612 |
| Contact | James Qi Zhang |
| Correspondent | James Qi Zhang Sunny Medical Device (Shenzhen) Co.,Ltd. 56 Lehigh Aisle Irvine, CA 92612 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-27 |
| Decision Date | 2016-11-10 |
| Summary: | summary |