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FDA 510(k) Application Details - K990288
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K990288
Device Name
Set, Administration, Intravascular
Applicant
TEVA MEDICAL, LTD.
482 HUDSON TERRACE
ENGLEWOOD CLIFFS, NJ 07632 US
Other 510(k) Applications for this Company
Contact
MARYANN MELUS
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
01/29/1999
Decision Date
02/24/1999
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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