SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER

Pump, Infusion, Insulin

SMITHS MEDICAL MD, INC.

The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Smiths Medical Insulin Infusion Pump With Cozmonitor Glucose Meter.

Pre-market Notification Details

Device IDK031738
510k NumberK031738
Device Name:SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
ClassificationPump, Infusion, Insulin
Applicant SMITHS MEDICAL MD, INC. 1265 GREY FOX ROAD St. Paul,  MN  55112
ContactRuss Davies
CorrespondentRuss Davies
SMITHS MEDICAL MD, INC. 1265 GREY FOX ROAD St. Paul,  MN  55112
Product CodeLZG  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-04
Decision Date2004-05-27
Summary:summary

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