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Innovasa, Inc.
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INNOVASA STAT*SEAL TOPICAL HEMOSTAT is an FDA 510(k)-cleared medical device (K071225) manufactured by Innovasa, 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 August 30, 2007. Regulation: 8.