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FDA 510(k) Application Details - K041152
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K041152
Device Name
Pump, Infusion
Applicant
APPLIED DIABETES RESEARCH, INC.
PO BOX 3900
DANA POINT, CA 92629 US
Other 510(k) Applications for this Company
Contact
JIM BARLEY
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
05/03/2004
Decision Date
05/24/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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