HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE

HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE is an FDA 510(k)-cleared medical device (K050163) manufactured by Henke Sass Wolf of America, Inc.. 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 March 23, 2005. Regulation: 8.