510(k) K021161

TSO3 OZONE CHEMICAL INDICATOR by Technologies of Sterilization With Oxone, Tso3, Inc. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2003
Date Received
April 11, 2002
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