ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS

Set, Administration, Intravascular

UNOMEDICAL A/S INFUSION DEVICES

The following data is part of a premarket notification filed by Unomedical A/s Infusion Devices with the FDA for Asante Conset And Asante Comfort Subcutaneous Infusion Sets For Use With Asante Pearl Infusion Pumps.

Pre-market Notification Details

Device IDK120872
510k NumberK120872
Device Name:ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS
ClassificationSet, Administration, Intravascular
Applicant UNOMEDICAL A/S INFUSION DEVICES AAHOLMVEJ 1-3, OSTED Lejre,  DK Dk-4320
ContactJohn M Lindskog
CorrespondentJohn M Lindskog
UNOMEDICAL A/S INFUSION DEVICES AAHOLMVEJ 1-3, OSTED Lejre,  DK Dk-4320
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-22
Decision Date2012-04-20
Summary:summary

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