STERILIZATION PROCESS CHANGE BOUNDARY

STERILIZATION PROCESS CHANGE BOUNDARY is an FDA 510(k)-cleared medical device (K792621) manufactured by Procter & Gamble Mfg. Co.. 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 January 10, 1980. Regulation: 8.