CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS

CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS is an FDA 510(k)-cleared medical device (K982369) manufactured by Allegiance Healthcare Corp.. 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 23, 1998. Regulation: 8.