FDA.report

510(k) K192641

Device
Gemini Titan Sterilization Wrap
Applicant
Medline Industries, Inc.
510(k) number
K192641
Product code
FRG  
Decision
Substantially Equivalent (SESE)
Decision date
2020-01-24
Date received
2019-09-24
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
Jennifer Mason
Address
Three Lakes Dr. Northfiled IL US 60093 60093

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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