POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS

Set, Administration, Intravascular

MEDTRONIC MINIMED

The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Polyfin Infusion Set, Models Mmt-165, Mmt-365, Mmt-366, Mmt-312s And Mmt-312l And Sof-set Infusion Sets.

Pre-market Notification Details

Device IDK100432
510k NumberK100432
Device Name:POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS
ClassificationSet, Administration, Intravascular
Applicant MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge,  CA  91325 -1219
ContactMark Faillace
CorrespondentMark Faillace
MEDTRONIC MINIMED 18000 DEVONSHIRE ST. Northridge,  CA  91325 -1219
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-16
Decision Date2010-07-09

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