
G.E.M. Water Systems
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G.E.M. WATER SYSTEMS, INTERNATIONAL is an FDA 510(k)-cleared medical device (K970674) manufactured by G.E.M. Water Systems. 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 November 18, 1997. Regulation: 8.