COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS

Set, Administration, Intravascular

UNOMEDICAL A/S

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

Pre-market Notification Details

Device IDK051264
510k NumberK051264
Device Name:COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS
ClassificationSet, Administration, Intravascular
Applicant UNOMEDICAL A/S AAHOLMVEJ 2, OSTED Roskilde,  DK 4000
ContactJohn Lindskog
CorrespondentJohn Lindskog
UNOMEDICAL A/S AAHOLMVEJ 2, OSTED Roskilde,  DK 4000
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-16
Decision Date2005-09-01
Summary:summary

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