Cleared Traditional

PROVOX VEGA, MODEL 8130-8135

K090455 · Atos Medical AB · Ear, Nose, Throat
Jun 2009
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K090455 is an FDA 510(k) clearance for the PROVOX VEGA, MODEL 8130-8135, a Prosthesis, Laryngeal (taub) (Class II — Special Controls, product code EWL), submitted by Atos Medical AB (Horby, SE). The FDA issued a Cleared decision on June 5, 2009, 102 days after receiving the submission on February 23, 2009. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3730.

Submission Details

510(k) Number K090455 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2009
Decision Date June 05, 2009
Days to Decision 102 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code EWL — Prosthesis, Laryngeal (taub)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3730

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