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FDA 510(k) Application Details - K024056
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K024056
Device Name
Pump, Infusion
Applicant
APPLIED DIABETES RESEARCH, INCORPORATED
28481 LAFALDA
LAGUNA NIGUEL, CA 92677 US
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Contact
JAMES BARLEY
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
12/09/2002
Decision Date
01/17/2003
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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