SILIMED GLUTEAL IMPLANT

SILIMED GLUTEAL IMPLANT is an FDA 510(k)-cleared medical device (K974482) manufactured by Silimed, LLC. 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 February 23, 1998. Regulation: 8.