510(k) K962649

SPORTROL RAPID STERILITY INDICATOR by North American Science Assoc., Inc. — Product Code MTC

K962649 is an FDA 510(k) premarket notification submitted by North American Science Assoc., Inc. for the device "SPORTROL RAPID STERILITY INDICATOR". The FDA issued a decision of Substantially Equivalent on September 26, 1997. The device falls under product code MTC (Indicator, Chemical, Enzymatic, Sterilization Process), a Class II device regulated under 21 CFR 880.2800. North American Science Assoc., Inc. has at least 5 other 510(k) clearances on record.