510(k) K951066

RAINS FRONTAL SINUS STENT by Smith & Nephew Richards, Inc. — Product Code KAM

K951066 is an FDA 510(k) premarket notification submitted by Smith & Nephew Richards, Inc. for the device "RAINS FRONTAL SINUS STENT". The FDA issued a decision of Substantially Equivalent on April 4, 1995. The device falls under product code KAM (Cannula, Sinus), a Class I device regulated under 21 CFR 878.4800. Smith & Nephew Richards, Inc. has at least 10 other 510(k) clearances on record.