510(k) K161910

Cardinal Health Sterilization Wrap by Cardinal Health200, LLC — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2017
Date Received
July 12, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type