The following data is part of a premarket notification filed by Dragon Heart Medical Devices Co., Ltd. with the FDA for Dragon Heart I.v. Set.
Device ID | K043235 |
510k Number | K043235 |
Device Name: | DRAGON HEART I.V. SET |
Classification | Set, Administration, Intravascular |
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 | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-11-22 |
Decision Date | 2005-03-08 |