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Ellman Int'L, Inc.
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SURGITRON RADIOLASE II is an FDA 510(k)-cleared medical device (K042710) manufactured by Ellman Int'L, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 6, 2005. Regulation: 8.