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FDA 510(k) Application Details - K020189
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K020189
Device Name
Set, Administration, Intravascular
Applicant
EXELINT INTERNATIONAL CO.
5840 W. CENTINELA AVE.
LOS ANGELES, CA 90231-3194 US
Other 510(k) Applications for this Company
Contact
TAMMIE EWING
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/18/2002
Decision Date
03/27/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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