
Medical Components, Inc.
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MEDCOMP BIO-FLEX CS CATHETER (CS100) is an FDA 510(k)-cleared medical device (K971925) manufactured by Medical Components, 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 22, 1998. Regulation: 8.