10.5 FRENCH DILATOR, 15CM, W/LUER LOCK

10.5 FRENCH DILATOR, 15CM, W/LUER LOCK is an FDA 510(k)-cleared medical device (K841995) manufactured by Quinton, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 1, 1984. Regulation: 8.