MEDLINE PVC URETHRAL CATHETER

Catheter, Straight

MEDLINE INDUSTRIES, INC.

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

Pre-market Notification Details

Device IDK100302
510k NumberK100302
Device Name:MEDLINE PVC URETHRAL CATHETER
ClassificationCatheter, Straight
Applicant MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
ContactMatt Clausen
CorrespondentMatt Clausen
MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
Product CodeEZD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-03
Decision Date2010-07-02

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