
Holter-Hausner Intl.
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H-H SEXTON SCUP URINE MGMT. SYS is an FDA 510(k)-cleared medical device (K853458) manufactured by Holter-Hausner Intl.. 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 August 26, 1985. Regulation: 8.