
Extracorporeal Medical Specialities, Inc.
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MODEL DM 353 & DM-353-L SINGLE NEEDLE is an FDA 510(k)-cleared medical device (K792174) manufactured by Extracorporeal Medical Specialities, 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 November 15, 1979. Regulation: 8.