FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM

Pump, Infusion, Insulin

ABBOTT DIABETES CARE INC.

The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Freestyle Aviator Insulin Delivery And Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK083225
510k NumberK083225
Device Name:FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
ClassificationPump, Infusion, Insulin
Applicant ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda,  CA  94502
ContactSarah Harrington
CorrespondentSarah Harrington
ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda,  CA  94502
Product CodeLZG  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-03
Decision Date2009-02-20
Summary:summary

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