Medtronic Extended Infusion Set

Set, Administration, Intravascular

Unomedical A/S

The following data is part of a premarket notification filed by Unomedical A/s with the FDA for Medtronic Extended Infusion Set.

Pre-market Notification Details

Device IDK210544
510k NumberK210544
Device Name:Medtronic Extended Infusion Set
ClassificationSet, Administration, Intravascular
Applicant Unomedical A/S Aaholmvej 1-3 Osted,  DK 4320
ContactLone Sylvest Vestergaard Jepsen
CorrespondentLone Sylvest Vestergaard Jepsen
Unomedical A/S Aaholmvej 1-3 Osted,  DK 4320
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-24
Decision Date2021-07-16

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