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FDA 510(k) Application Details - K092172
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K092172
Device Name
Set, Administration, Intravascular
Applicant
EXELINT INTL. CO.
5840 WEST CENTINELA AVE.
LOS ANGELES, CA 90045 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
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/21/2009
Decision Date
01/04/2010
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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