TYGON PAC-MONITORING LINES & FLUID ADMIN

TYGON PAC-MONITORING LINES & FLUID ADMIN is an FDA 510(k)-cleared medical device (K770707) 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 2, 1977. Regulation: 8.