NEXUS INJECTION SITE (NIS), MODEL NIS-1

Set, Administration, Intravascular

NEXUS MEDICAL, LLC

The following data is part of a premarket notification filed by Nexus Medical, Llc with the FDA for Nexus Injection Site (nis), Model Nis-1.

Pre-market Notification Details

Device IDK024363
510k NumberK024363
Device Name:NEXUS INJECTION SITE (NIS), MODEL NIS-1
ClassificationSet, Administration, Intravascular
Applicant NEXUS MEDICAL, LLC 11428 LOSTWOOD LN. SUITE B Raleigh,  NC  27614
ContactJamie Abourched
CorrespondentJamie Abourched
NEXUS MEDICAL, LLC 11428 LOSTWOOD LN. SUITE B Raleigh,  NC  27614
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-31
Decision Date2003-02-19

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