510(k) K800482

STEAROTHERMOHILUS SPORE STRIPS by Mdt Corp., Inc. — Product Code FRC

K800482 is an FDA 510(k) premarket notification submitted by Mdt Corp., Inc. for the device "STEAROTHERMOHILUS SPORE STRIPS". The FDA issued a decision of Substantially Equivalent on April 16, 1980. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Mdt Corp., Inc. has at least 10 other 510(k) clearances on record.