INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE

INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE is an FDA 510(k)-cleared medical device (K945287) manufactured by Helix Medical, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 8, 1994. Regulation: 8.