SPLIT SEPTUM INJECTION SITES

Set, Administration, Intravascular

FRESENIUS MEDICAL CARE NORTH AMERICA

The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Split Septum Injection Sites.

Pre-market Notification Details

Device IDK041042
510k NumberK041042
Device Name:SPLIT SEPTUM INJECTION SITES
ClassificationSet, Administration, Intravascular
Applicant FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington,  MA  02420 -9192
ContactArthur Eilinsfeld
CorrespondentArthur Eilinsfeld
FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington,  MA  02420 -9192
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-22
Decision Date2004-07-16
Summary:summary

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