MAERSK MEDICAL CONTOUR 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 Maersk Medical Contour Infusion Set.

Pre-market Notification Details

Device IDK991759
510k NumberK991759
Device Name:MAERSK MEDICAL CONTOUR INFUSION SET
ClassificationSet, Administration, Intravascular
Applicant MAERSK MEDICAL A/S 12744 SAN FERNANDO RD. Sylmar,  CA  91342
ContactDon Selvey
CorrespondentDon Selvey
MAERSK MEDICAL A/S 12744 SAN FERNANDO RD. Sylmar,  CA  91342
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-24
Decision Date1999-06-25
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.