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FDA 510(k) Application Details - K973025
Device Classification Name
Monitor, Electric For Gravity Flow Infusion Systems
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510(K) Number
K973025
Device Name
Monitor, Electric For Gravity Flow Infusion Systems
Applicant
NORTHGATE TECHNOLOGIES, INC.
600 CHURCH RD.
ELGIN, IL 60123 US
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Contact
CASEY KUREK
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Regulation Number
880.2420
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Classification Product Code
FLN
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More FDA Info for this Product Code
Date Received
08/14/1997
Decision Date
11/20/1997
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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