FDA.report

510(k) K130927

Device
DURABLUE STERILIZATION WRAP
Applicant
CARDINAL HEALTH 200, LLC
510(k) number
K130927
Product code
FRG  
Decision
Substantially Equivalent (SESE)
Decision date
2013-06-18
Date received
2013-04-03
Regulation
880.6850
Classification name
Wrap, Sterilization
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
LAVENIA FORD
Address
1430 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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