SILASTIC TENDON PASSER H.P.

SILASTIC TENDON PASSER H.P. is an FDA 510(k)-cleared medical device (K811679) manufactured by Dow Corning Corp. Healthcare Industries Materials. This device is classified under the Orthopedic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 9, 1981. Regulation: 8.