510(k) K003533

CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L by Steritec Products, Inc. — Product Code JOJ

K003533 is an FDA 510(k) premarket notification submitted by Steritec Products, Inc. for the device "CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L". The FDA issued a decision of Substantially Equivalent on February 7, 2001. 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.