510(k) K951063

ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION by Pymah Corp. — Product Code JOJ

K951063 is an FDA 510(k) premarket notification submitted by Pymah Corp. for the device "ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION". The FDA issued a decision of Substantially Equivalent on May 10, 1995. 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.