510(k) K910691

NORTEC URETERAL STENT by North American Sterilization & Packaging Co. — Product Code FAD

K910691 is an FDA 510(k) premarket notification submitted by North American Sterilization & Packaging Co. for the device "NORTEC URETERAL STENT". The FDA issued a decision of Substantially Equivalent on August 15, 1991. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. North American Sterilization & Packaging Co. has at least 10 other 510(k) clearances on record.