510(k) K151445

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2015
Date Received
May 29, 2015
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