I-FLOW ELASTOMERIC PUMP

Pump, Infusion, Elastomeric

I-FLOW CORP.

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

Pre-market Notification Details

Device IDK020862
510k NumberK020862
Device Name:I-FLOW ELASTOMERIC PUMP
ClassificationPump, Infusion, Elastomeric
Applicant I-FLOW CORP. 20202 WINDROW DR. Lake Forest,  CA  92630
ContactShane Noehre
CorrespondentShane Noehre
I-FLOW CORP. 20202 WINDROW DR. Lake Forest,  CA  92630
Product CodeMEB  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-18
Decision Date2002-03-26
Summary:summary

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