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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K043235
Device Name DRAGON HEART I.V. SET
Applicant
DRAGON HEART MEDICAL DEVICES CO., LTD.
188 INDUSTRIAL DRIVE
SUITE 108
ELMHURST,  IL  60126
Applicant Contact JINA YU
Correspondent
DRAGON HEART MEDICAL DEVICES CO., LTD.
188 INDUSTRIAL DRIVE
SUITE 108
ELMHURST,  IL  60126
Correspondent Contact JINA YU
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/22/2004
Decision Date 03/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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