HANSON MEDICAL GLUTEAL IMPLANT

HANSON MEDICAL GLUTEAL IMPLANT is an FDA 510(k)-cleared medical device (K030809) manufactured by Hanson Medical, 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 April 20, 2003. Regulation: 8.