MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM

MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM is an FDA 510(k)-cleared medical device (K081542) manufactured by Entellus Medical, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 26, 2008. Regulation: 8.