The following data is part of a premarket notification filed by Dragon Heart Medical Devices Co., Ltd. with the FDA for Dragon Heart Piston Syringe.
| Device ID | K042547 |
| 510k Number | K042547 |
| Device Name: | DRAGON HEART PISTON SYRINGE |
| Classification | Syringe, Piston |
| Applicant | DRAGON HEART MEDICAL DEVICES CO., LTD. 188 INDUSTRIAL DRIVE SUITE 108 Elmhurst, IL 60126 |
| Contact | Jina Yu |
| Correspondent | Jina Yu DRAGON HEART MEDICAL DEVICES CO., LTD. 188 INDUSTRIAL DRIVE SUITE 108 Elmhurst, IL 60126 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-20 |
| Decision Date | 2004-12-01 |