DRAGON HEART I.V. SET

Set, Administration, Intravascular

DRAGON HEART MEDICAL DEVICES CO., LTD.

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.

Pre-market Notification Details

Device IDK043235
510k NumberK043235
Device Name:DRAGON HEART I.V. SET
ClassificationSet, Administration, Intravascular
Applicant DRAGON HEART MEDICAL DEVICES CO., LTD. 188 INDUSTRIAL DRIVE SUITE 108 Elmhurst,  IL  60126
ContactJina Yu
CorrespondentJina Yu
DRAGON HEART MEDICAL DEVICES CO., LTD. 188 INDUSTRIAL DRIVE SUITE 108 Elmhurst,  IL  60126
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-22
Decision Date2005-03-08

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