Cleared Traditional

K080032 - ENVOYCEM, MODEL 1640
(FDA 510(k) Clearance)

K080032 · Envoy Medical Corporation · Ear, Nose, Throat device

Feb 2008

Decision

52d

Days

Class 2

Risk

K080032 is an FDA 510(k) clearance for the ENVOYCEM, MODEL 1640. This device is classified as a Cement, Ear, Nose And Throat (Class II - Special Controls, product code NEA).

Submitted by Envoy Medical Corporation (St. Paul, US). The FDA issued a Cleared decision on February 28, 2008, 52 days after receiving the submission on January 7, 2008.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K080032 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 07, 2008
Decision Date	February 28, 2008
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF