SILASTIC INFLATABLE BONE PLUG H.P.

SILASTIC INFLATABLE BONE PLUG H.P. is an FDA 510(k)-cleared medical device (K853186) manufactured by Dow Corning Corp. Healthcare Industries Materials. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 23, 1985. Regulation: 8.