510(k) K891366

BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.) by Mdt Corp., Inc. — Product Code FRC

K891366 is an FDA 510(k) premarket notification submitted by Mdt Corp., Inc. for the device "BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.)". The FDA issued a decision of Substantially Equivalent on March 29, 1989. 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.