
Dyonics, Inc.
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PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM is an FDA 510(k)-cleared medical device (K880150) manufactured by Dyonics, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 3, 1988. Regulation: 8.