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FDA 510(k) Application Details - K991203
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K991203
Device Name
Pump, Infusion
Applicant
KMI KOLSTER METHODS, INC.
2550 WEST ROWLAND AVE.
ANAHEIM, CA 92804 US
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Contact
ALWIN H KOLSTER
Other 510(k) Applications for this Contact
Regulation Number
880.5725
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Classification Product Code
FRN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/08/1999
Decision Date
10/15/1999
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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