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FDA 510(k) Application Details - K024190
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K024190
Device Name
Pump, Infusion
Applicant
PROMEDIC, INC.
6329 WEST WATERVIEW CT.
MCCORDSVILLE, IN 46055-9501 US
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Contact
PAUL DRYDEN
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
FRN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/19/2002
Decision Date
03/17/2003
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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