DRAGON HEART PISTON SYRINGE

Syringe, Piston

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 Piston Syringe.

Pre-market Notification Details

Device IDK042547
510k NumberK042547
Device Name:DRAGON HEART PISTON SYRINGE
ClassificationSyringe, Piston
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 CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-20
Decision Date2004-12-01

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