510(k) K140703

OPA 30 SOLUTION by Ciden Technologies, LLC — Product Code MED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2014
Date Received
March 20, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilant, Medical Devices
Device Class
Class II
Regulation Number
880.6885
Review Panel
HO
Submission Type