MAINSTREAM WATER PURIFICATION DEVICE

MAINSTREAM WATER PURIFICATION DEVICE is an FDA 510(k)-cleared medical device (K012716) manufactured by Prismedical Corp.. 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 May 6, 2002. Regulation: 8.