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FDA 510(k) Application Details - K990711
Device Classification Name
Set, I.V. Fluid Transfer
More FDA Info for this Device
510(K) Number
K990711
Device Name
Set, I.V. Fluid Transfer
Applicant
CODAN US CORP.
3511 WEST SUNFLOWER AVE.
SANTA ANA, CA 92704-6944 US
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Contact
FERGIE FERGUSON
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
LHI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/04/1999
Decision Date
04/13/1999
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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