510(k) K111518

STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 by Advanced Sterilization Products — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2012
Date Received
June 2, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type