SHANGHAI GANGHAI MODEL GIKO 1400

SHANGHAI GANGHAI MODEL GIKO 1400 is an FDA 510(k)-cleared medical device (K063334) manufactured by Shanghai Gangkai Purifying Products Co., Ltd.. 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 December 7, 2006. Regulation: 8.