K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)

Set, Administration, Intravascular

KAWASUMI LABORATORIES, INC.

The following data is part of a premarket notification filed by Kawasumi Laboratories, Inc. with the FDA for K-shield Advantage Port Access Infusion Set (pais).

Pre-market Notification Details

Device IDK123344
510k NumberK123344
Device Name:K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)
ClassificationSet, Administration, Intravascular
Applicant KAWASUMI LABORATORIES, INC. 7401 104TH AVE. STE 160 Kenosha,  WI  53142
ContactChristina Henza
CorrespondentChristina Henza
KAWASUMI LABORATORIES, INC. 7401 104TH AVE. STE 160 Kenosha,  WI  53142
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-31
Decision Date2013-03-07
Summary:summary

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