PRIMAEVA MEDICAL RENESIS SYSTEM

PRIMAEVA MEDICAL RENESIS SYSTEM is an FDA 510(k)-cleared medical device (K082391) manufactured by Primaeva Medical, Inc.. 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 August 31, 2009. Regulation: 8.