FDA.report

510(k) K192374

Device
Cardinal Health™ Level 3 Surgical Mask With Anti-Fog Foam Strip
Applicant
Cardinal Health 200, LLC
510(k) number
K192374
Product code
FXX  
Decision
Substantially Equivalent (SESE)
Decision date
2019-12-02
Date received
2019-08-30
Regulation
878.4040
Classification name
Mask, 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
Dominic Tunzi
Address
3651 Birchwood Dr. Waukegan IL US 60085 60085

FDA Registration Numbers

Source Documents

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

Legacy Summary

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FDA Review

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