510(k) K122555

STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE by Steritec Products Mfg Co, Inc. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2012
Date Received
August 22, 2012
Clearance Type
Abbreviated
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