VYGON BALLOON FOR IDENTIFICATION OF EPIDURAL 193

VYGON BALLOON FOR IDENTIFICATION OF EPIDURAL 193 is an FDA 510(k)-cleared medical device (K851479) manufactured by Vygon Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 13, 1985. Regulation: 8.