
Dornier Medtech America, Inc.
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Delta III Pro is an FDA 510(k)-cleared medical device (K221903) manufactured by Dornier Medtech 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 February 21, 2023. Regulation: 8.