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Scholten Surgical Instruments, Inc.
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NOVATOME, MODEL: SU101-50 is an FDA 510(k)-cleared medical device (K072051) manufactured by Scholten Surgical Instruments, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 2, 2007. Regulation: 8.