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FDA 510(k) Application Details - K101368
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K101368
Device Name
Set, Administration, Intravascular
Applicant
DRAGON HEART MEDICAL, INC.
205 W GRAND AVE
SUITE 105
BENSENVILLE, IL US
Other 510(k) Applications for this Company
Contact
JINA YU
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/17/2010
Decision Date
11/18/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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