TISSUELINK FLOATING BALL MODEL 23-201-1

TISSUELINK FLOATING BALL MODEL 23-201-1 is an FDA 510(k)-cleared medical device (K032132) manufactured by Tissuelink Medical, Inc.. 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 August 19, 2003. Regulation: 8.