510(k) K952995

ATI ETHYLENE OXIDE STERILIZATION INDICATOR by Pymah Corp. — Product Code JOJ

K952995 is an FDA 510(k) premarket notification submitted by Pymah Corp. for the device "ATI ETHYLENE OXIDE STERILIZATION INDICATOR". The FDA issued a decision of Substantially Equivalent on February 22, 1996. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Pymah Corp. has at least 10 other 510(k) clearances on record.