
Neothermia Corp.
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MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM is an FDA 510(k)-cleared medical device (K023413) manufactured by Neothermia Corp.. 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 November 7, 2002. Regulation: 8.