PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE

PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE is an FDA 510(k)-cleared medical device (K901920) manufactured by Primecare, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 16, 1990. Regulation: 8.