PSD-60/ENDOPLASMA

PSD-60/ENDOPLASMA is an FDA 510(k)-cleared medical device (K042274) manufactured by Olympus Shirakawa 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 February 21, 2005. Regulation: 8.