ANIMAS MODEL IR1250 INSULIN INFUSION PUMP

Pump, Infusion, Insulin

ANIMAS CORP.

The following data is part of a premarket notification filed by Animas Corp. with the FDA for Animas Model Ir1250 Insulin Infusion Pump.

Pre-market Notification Details

Device IDK042873
510k NumberK042873
Device Name:ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
ClassificationPump, Infusion, Insulin
Applicant ANIMAS CORP. 200 LAWRENCE DR. West Chester,  PA  19380
ContactThomas L Parker
CorrespondentThomas L Parker
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 Received2004-10-18
Decision Date2004-12-10
Summary:summary

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