
Ballard Medical Products
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BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT is an FDA 510(k)-cleared medical device (K993138) 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 October 19, 1999. Regulation: 8.