SOF. PRESS EPC 51 SYSTEM

SOF. PRESS EPC 51 SYSTEM is an FDA 510(k)-cleared medical device (K963067) manufactured by Gaymar Industries, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 27, 1997. Regulation: 8.