
Lafayette Pharmacal, Inc.
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ENTROKIT WITH MAGLINTE CATHETER is an FDA 510(k)-cleared medical device (K860441) manufactured by Lafayette Pharmacal, 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 March 11, 1986. Regulation: 8.