510(k) K972300

CROSS-CHECKS P by Steritec Products Mfg Co, Inc. — Product Code JOJ

K972300 is an FDA 510(k) premarket notification submitted by Steritec Products Mfg Co, Inc. for the device "CROSS-CHECKS P". The FDA issued a decision of Substantially Equivalent on March 25, 1998. 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 25, 1998
Date Received
June 19, 1997
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