MOSS(R) STEEL BREAKAWAY(R) INTRODUCER

MOSS(R) STEEL BREAKAWAY(R) INTRODUCER is an FDA 510(k)-cleared medical device (K945480) manufactured by Harry A. Schlakman. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 27, 1995. Regulation: 8.