MEDLINE LATEX FOLEY CATHETER

Catheter, Retention Type, Balloon

MEDLINE INDUSTRIES, INC.

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

Pre-market Notification Details

Device IDK071423
510k NumberK071423
Device Name:MEDLINE LATEX FOLEY CATHETER
ClassificationCatheter, Retention Type, Balloon
Applicant MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
ContactMatt Clausen
CorrespondentMatt Clausen
MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-22
Decision Date2007-07-18
Summary:summary

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