FDA.report

510(k) K172954

Device
Medline Prevention CoolZone Gown
Applicant
Medline Industries, Inc.
510(k) number
K172954
Product code
FYA  
Decision
Substantially Equivalent (SESE)
Decision date
2018-06-15
Date received
2017-09-26
Regulation
878.4040
Classification name
Gown, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
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
Pauline Maralit
Address
3 Lakes Dr. Northfield 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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