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FDA 510(k) Application Details - K083225
Device Classification Name
Pump, Infusion, Insulin
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510(K) Number
K083225
Device Name
Pump, Infusion, Insulin
Applicant
ABBOTT DIABETES CARE INC.
1360 SOUTH LOOP RD.
ALAMEDA, CA 94502 US
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Contact
SARAH HARRINGTON
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Regulation Number
880.5725
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Classification Product Code
LZG
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More FDA Info for this Product Code
Date Received
11/03/2008
Decision Date
02/20/2009
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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