SYMPHONY GLUCOSE MANAGEMENT SYSTEM

Pump, Infusion, Insulin

ANIMAS CORP.

The following data is part of a premarket notification filed by Animas Corp. with the FDA for Symphony Glucose Management System.

Pre-market Notification Details

Device IDK080639
510k NumberK080639
Device Name:SYMPHONY GLUCOSE MANAGEMENT SYSTEM
ClassificationPump, Infusion, Insulin
Applicant ANIMAS CORP. 200 LAWRENCE DR. West Chester,  PA  19380
ContactAmy Smith
CorrespondentAmy Smith
ANIMAS CORP. 200 LAWRENCE DR. West Chester,  PA  19380
Product CodeLZG  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-06
Decision Date2008-06-24
Summary:summary

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