PARIETEX POLYESTER MESH WITH INTRODUCER

PARIETEX POLYESTER MESH WITH INTRODUCER is an FDA 510(k)-cleared medical device (K071629) manufactured by Sofradim Production. 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 July 9, 2007. Regulation: 8.