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Ellman Int'L, Inc.
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ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC is an FDA 510(k)-cleared medical device (K082834) 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 May 6, 2009. Regulation: 8.