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FDA 510(k) Application Details - K952799
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K952799
Device Name
Pump, Infusion
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
D389, AP30
ABBOTT PARK, IL 60064 US
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Contact
DAVID T GUZEK
Other 510(k) Applications for this Contact
Regulation Number
880.5725
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Classification Product Code
FRN
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More FDA Info for this Product Code
Date Received
06/19/1995
Decision Date
01/18/1996
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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