MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT

MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT is an FDA 510(k)-cleared medical device (K982894) manufactured by Ballard Medical Products. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 1998. Regulation: 8.