NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET

Set, Administration, Intravascular

NIPRO MEDICAL CORPORATION

The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Nipro Huber Infusion Set, Excel Huber Infusion Set.

Pre-market Notification Details

Device IDK113471
510k NumberK113471
Device Name:NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET
ClassificationSet, Administration, Intravascular
Applicant NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami,  FL  33172
ContactJessica Oswald
CorrespondentJessica Oswald
NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami,  FL  33172
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-22
Decision Date2012-10-18
Summary:summary

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