MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES

MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES is an FDA 510(k)-cleared medical device (K122653) manufactured by Kimberly-Clark Corporation. 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 June 25, 2013. Regulation: 8.