SEPRAGEL ENT BIORESORBABLE PACKING/STENT

SEPRAGEL ENT BIORESORBABLE PACKING/STENT is an FDA 510(k)-cleared medical device (K043035) manufactured by Genzyme Corporation. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 10, 2005. Regulation: 8.