N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN)

N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN) is an FDA 510(k)-cleared medical device (K932003) manufactured by National Healthcare Linen Service. 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 June 10, 1993. Regulation: 8.