
Lafayette Pharmaceuticals, Inc.
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PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL is an FDA 510(k)-cleared medical device (K934585) manufactured by Lafayette Pharmaceuticals, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 2, 1993. Regulation: 8.