GLUCOPRO EVO INFUSION PUMP

Pump, Infusion, Insulin

NIPRO DIABETES SYSTEMS, INC.

The following data is part of a premarket notification filed by Nipro Diabetes Systems, Inc. with the FDA for Glucopro Evo Infusion Pump.

Pre-market Notification Details

Device IDK013309
510k NumberK013309
Device Name:GLUCOPRO EVO INFUSION PUMP
ClassificationPump, Infusion, Insulin
Applicant NIPRO DIABETES SYSTEMS, INC. 1384 COPPERFIELD COURT Lexington,  KY  40514
ContactKaelyn B Hadley
CorrespondentKaelyn B Hadley
NIPRO DIABETES SYSTEMS, INC. 1384 COPPERFIELD COURT Lexington,  KY  40514
Product CodeLZG  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-04
Decision Date2002-06-24
Summary:summary

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