FDA.report

510(k) K202447

Device
Medline Orbis Surgical Gown
Applicant
Medline Industries, Inc.
510(k) number
K202447
Product code
FYA  
Decision
Substantially Equivalent (SESE)
Decision date
2021-04-02
Date received
2020-08-26
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
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Adam Ostrower
Address
Three Lakes Dr. Northfiled IL US 60093 60093

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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