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FDA 510(k) Application Details - K070125
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K070125
Device Name
Pump, Infusion
Applicant
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK, IL 60085 US
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Contact
JEME WALLACE
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
01/16/2007
Decision Date
04/16/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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