
Esb, Inc., Div. of Ray-O-Vac
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ESB 2400 SEI is an FDA 510(k)-cleared medical device (K933146) manufactured by Esb, Inc., Div. of Ray-O-Vac. 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 September 22, 1993. Regulation: 8.