510(k) K000502

STEAM/EO RECORD CARD, MODEL CI 121 by Steritec Products Mfg Co, Inc. — Product Code JOJ

K000502 is an FDA 510(k) premarket notification submitted by Steritec Products Mfg Co, Inc. for the device "STEAM/EO RECORD CARD, MODEL CI 121". The FDA issued a decision of Substantially Equivalent on March 14, 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 Mfg Co, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2000
Date Received
February 15, 2000
Clearance Type
Special
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