R&D PART 5518, 5306, 5315 AND 5457

R&D PART 5518, 5306, 5315 AND 5457 is an FDA 510(k)-cleared medical device (K945867) manufactured by R & D Batteries, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 28, 1994. Regulation: 8.