Medline Catheter Specimen Collector

Catheter, Straight

Medline Industries, Inc.

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

Pre-market Notification Details

Device IDK172541
510k NumberK172541
Device Name:Medline Catheter Specimen Collector
ClassificationCatheter, Straight
Applicant Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
ContactDinah Rincones
CorrespondentDinah Rincones
Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodeEZD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-23
Decision Date2018-02-22
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.