510(k) K003002

STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123 by Steritec Products, Inc. — Product Code JOJ

K003002 is an FDA 510(k) premarket notification submitted by Steritec Products, Inc. for the device "STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123". The FDA issued a decision of Substantially Equivalent on December 8, 2000. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Steritec Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2000
Date Received
September 26, 2000
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