PARADIGM QUICK-SET INFUSION SET

Set, Administration, Intravascular

MAERSK MEDICAL A/S

The following data is part of a premarket notification filed by Maersk Medical A/s with the FDA for Paradigm Quick-set Infusion Set.

Pre-market Notification Details

Device IDK011071
510k NumberK011071
Device Name:PARADIGM QUICK-SET INFUSION SET
ClassificationSet, Administration, Intravascular
Applicant MAERSK MEDICAL A/S 18000 DEVONSHIRE ST. Northridge,  CA  91325 -1219
ContactGerda Resch
CorrespondentGerda Resch
MAERSK MEDICAL A/S 18000 DEVONSHIRE ST. Northridge,  CA  91325 -1219
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-09
Decision Date2001-06-07

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