FULL SPECTRUM ULE FIBER, MODEL FF101

FULL SPECTRUM ULE FIBER, MODEL FF101 is an FDA 510(k)-cleared medical device (K920596) manufactured by Gerald J. Shirk, M.D.. 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 5, 1994. Regulation: 8.