Sunmed Control Syringes

Sunmed Control Syringes is an FDA 510(k)-cleared medical device (K160190) manufactured by Sunny Medical Device (Shenzhen) Co., Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 9, 2016. Regulation: 8.