
Bio-Research Associates, Inc.
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NEEDLE CATHETER JEJUNOSTOMY KIT is an FDA 510(k)-cleared medical device (K822565) manufactured by Bio-Research Associates, 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 September 27, 1982. Regulation: 8.