510(k) K093594

MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER by Acclarent, Inc. — Product Code KAM

K093594 is an FDA 510(k) premarket notification submitted by Acclarent, Inc. for the device "MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER". The FDA issued a decision of Substantially Equivalent on March 3, 2010. 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.