
Erbe USA, Inc.
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ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094 is an FDA 510(k)-cleared medical device (K062712) manufactured by Erbe USA, 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 January 25, 2007. Regulation: 8.