
Medical Components, Inc.
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MCSCP8PS WITH 'Y' HUB is an FDA 510(k)-cleared medical device (K821684) 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 June 23, 1982. Regulation: 8.