FDA.report

510(k) K161910

Device
Cardinal Health Sterilization Wrap
Applicant
CARDINAL HEALTH 200, LLC
510(k) number
K161910
Product code
FRG  
Decision
Substantially Equivalent (SESE)
Decision date
2017-04-20
Date received
2016-07-12
Regulation
880.6850
Classification name
Wrap, Sterilization
Medical specialty
General Hospital
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
MEGAN MIDDAUGH
Address
1500 Waukegan Rd. Waukegan IL US 60085 60085

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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