Medline Epidural Catheter

Catheter, Conduction, Anesthetic

MEDLINE INDUSTRIES, INC.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Epidural Catheter.

Pre-market Notification Details

Device IDK150731
510k NumberK150731
Device Name:Medline Epidural Catheter
ClassificationCatheter, Conduction, Anesthetic
Applicant MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
ContactMatt Clausen
CorrespondentMatt Clausen
MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
Product CodeBSO  
CFR Regulation Number868.5120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-20
Decision Date2016-03-07
Summary:summary

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