
Ellman Intl., Inc.
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SUGITRON MODEL: IEC is an FDA 510(k)-cleared medical device (K980177) manufactured by Ellman Intl., 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 July 6, 1998. Regulation: 8.