ON-Q INTRODUCERS

Catheter, Conduction, Anesthetic

I-FLOW CORP.

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

Pre-market Notification Details

Device IDK063234
510k NumberK063234
Device Name:ON-Q INTRODUCERS
ClassificationCatheter, Conduction, Anesthetic
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 CodeBSO  
CFR Regulation Number868.5120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-25
Decision Date2006-11-21
Summary:summary

NIH GUDID Devices

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