MODEL IR 1200 INSULIN PUMP

Pump, Infusion, Insulin

ANIMAS CORP.

The following data is part of a premarket notification filed by Animas Corp. with the FDA for Model Ir 1200 Insulin Pump.

Pre-market Notification Details

Device IDK032257
510k NumberK032257
Device Name:MODEL IR 1200 INSULIN PUMP
ClassificationPump, Infusion, Insulin
Applicant ANIMAS CORP. 590 E. LANCASTER AVE. Frazer,  PA  19355
ContactMichael J Andrews
CorrespondentMichael J Andrews
ANIMAS CORP. 590 E. LANCASTER AVE. Frazer,  PA  19355
Product CodeLZG  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-22
Decision Date2003-10-16
Summary:summary

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