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 |