510(k) K001649

STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 by Steritec Products, Inc. — Product Code JOJ

K001649 is an FDA 510(k) premarket notification submitted by Steritec Products, Inc. for the device "STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234". The FDA issued a decision of Substantially Equivalent on June 23, 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.