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FDA 510(k) Application Details - K010197
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K010197
Device Name
Set, Administration, Intravascular
Applicant
EXELINT INTERNATIONAL CO.
5840 W. CENTINELA AVE.
LOS ANGELES, CA 90231-3194 US
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Contact
ARMAND HAMID
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
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More FDA Info for this Product Code
Date Received
01/22/2001
Decision Date
05/14/2001
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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