Cleared Traditional

THE GRONINGEN VOICE PROSTHESIS

K853940 · Hood Laboratories · Ear, Nose, Throat
Dec 1985
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K853940 is an FDA 510(k) clearance for the THE GRONINGEN VOICE PROSTHESIS, a Prosthesis, Laryngeal (taub) (Class II — Special Controls, product code EWL), submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on December 13, 1985, 80 days after receiving the submission on September 24, 1985. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3730.

Submission Details

510(k) Number K853940 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 1985
Decision Date December 13, 1985
Days to Decision 80 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

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

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