HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01

HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01 is an FDA 510(k)-cleared medical device (K041504) manufactured by Haemacure Corp.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 5, 2004. Regulation: 8.