
Mattioli Engineering Corp.
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TRANSDERM IONTO SYSTEM, MK 2 is an FDA 510(k)-cleared medical device (K042590) manufactured by Mattioli Engineering Corp.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 13, 2004. Regulation: 8.