510(k) K981497

STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS by Steritec Products Mfg Co, Inc. — Product Code FRC

K981497 is an FDA 510(k) premarket notification submitted by Steritec Products Mfg Co, Inc. for the device "STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS". The FDA issued a decision of Substantially Equivalent on October 29, 1998. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Steritec Products Mfg Co, Inc. has at least 10 other 510(k) clearances on record.