510(k) K863122

ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. by Surgicot, Inc. — Product Code FRC

K863122 is an FDA 510(k) premarket notification submitted by Surgicot, Inc. for the device "ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.". The FDA issued a decision of Substantially Equivalent on December 17, 1986. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Surgicot, Inc. has at least 10 other 510(k) clearances on record.