510(k) K894398

STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE by Pymah Corp. — Product Code FRC

K894398 is an FDA 510(k) premarket notification submitted by Pymah Corp. for the device "STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE". The FDA issued a decision of Substantially Equivalent on September 11, 1989. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Pymah Corp. has at least 10 other 510(k) clearances on record.