PARAGON INFUSION

Set, Administration, Intravascular

I-FLOW CORP.

The following data is part of a premarket notification filed by I-flow Corp. with the FDA for Paragon Infusion.

Pre-market Notification Details

Device IDK984146
510k NumberK984146
Device Name:PARAGON INFUSION
ClassificationSet, Administration, Intravascular
Applicant I-FLOW CORP. 20202 WINDROW DR. Lake Forest,  CA  92630
ContactRobert J Bard
CorrespondentRobert J Bard
I-FLOW CORP. 20202 WINDROW DR. Lake Forest,  CA  92630
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-19
Decision Date1999-02-09
Summary:summary

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