
Medireach, Inc.
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PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE is an FDA 510(k)-cleared medical device (K890072) manufactured by Medireach, 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 June 11, 1989. Regulation: 8.