SUPPLEMENTAL TYGON PAC-MONITORING LINES

SUPPLEMENTAL TYGON PAC-MONITORING LINES is an FDA 510(k)-cleared medical device (K780662) manufactured by Norton Performance Plastics Corp.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 5, 1978. Regulation: 8.