
The Healthcare Group Laboratories, Inc.
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URINARY COLLECTION CONTAINER/LEG BAG is an FDA 510(k)-cleared medical device (K821171) manufactured by The Healthcare Group Laboratories, 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 May 9, 1982. Regulation: 8.