RUTTER SUPRA STOMAL STENTS

RUTTER SUPRA STOMAL STENTS is an FDA 510(k)-cleared medical device (K091135) manufactured by Boston Medical Products, Inc.. 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 September 13, 2009. Regulation: 8.