NEXUS INJECTION SITE, MODEL NIS-8

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, Model Nis-8.

Pre-market Notification Details

Device IDK092527
510k NumberK092527
Device Name:NEXUS INJECTION SITE, MODEL NIS-8
ClassificationSet, Administration, Intravascular
Applicant NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD Lenexa,  KS  66215
ContactHeather Turner
CorrespondentHeather Turner
NEXUS MEDICAL, LLC 11315 STRANG LINE ROAD Lenexa,  KS  66215
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-18
Decision Date2010-02-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30892855000875 K092527 000
30892855000714 K092527 000

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