FDA.report

510(k) K172541

Device
Medline Catheter Specimen Collector
Applicant
Medline Industries, Inc.
510(k) number
K172541
Product code
EZD  
Decision
Substantially Equivalent (SESE)
Decision date
2018-02-22
Date received
2017-08-23
Regulation
876.5130
Classification name
Catheter, Straight
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Dinah Rincones
Address
Three Lakes Dr. Northfiled IL US 60093 60093

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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