510(k) K090455

PROVOX VEGA, MODEL 8130-8135 by Atos Medical AB — Product Code EWL

K090455 is an FDA 510(k) premarket notification submitted by Atos Medical AB for the device "PROVOX VEGA, MODEL 8130-8135". The FDA issued a decision of Substantially Equivalent on June 5, 2009. The device falls under product code EWL (Prosthesis, Laryngeal (Taub)), a Class II device regulated under 21 CFR 874.3730. Atos Medical AB has at least 10 other 510(k) clearances on record.