CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH

CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH is an FDA 510(k)-cleared medical device (K933050) manufactured by Critikon Company, LLC. 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 December 13, 1993. Regulation: 8.