APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE

APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE is an FDA 510(k)-cleared medical device (K081710) manufactured by American Medical Systems. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on October 14, 2008. Regulation: 8.