510(k) K071845

RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A by Acclarent, Inc. — Product Code KAM

K071845 is an FDA 510(k) premarket notification submitted by Acclarent, Inc. for the device "RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A". The FDA issued a decision of Substantially Equivalent on September 28, 2007. The device falls under product code KAM (Cannula, Sinus), a Class I device regulated under 21 CFR 878.4800. Acclarent, Inc. has at least 10 other 510(k) clearances on record.