510(k) K896821

OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE by North American Sterilization & Packaging Co. — Product Code KOQ

K896821 is an FDA 510(k) premarket notification submitted by North American Sterilization & Packaging Co. for the device "OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE". The FDA issued a decision of Substantially Equivalent on February 9, 1990. The device falls under product code KOQ (Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)), a Class I device regulated under 21 CFR 872.3410. North American Sterilization & Packaging Co. has at least 10 other 510(k) clearances on record.