Cleared Traditional

K083783 - VF LIQUIGEL
(FDA 510(k) Clearance)

K083783 · Coapt Systems, Inc. · Ear, Nose, Throat device

Sep 2009

Decision

266d

Days

Class 2

Risk

K083783 is an FDA 510(k) clearance for the VF LIQUIGEL. This device is classified as a System, Vocal Cord Medialization (Class II - Special Controls, product code MIX).

Submitted by Coapt Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on September 11, 2009, 266 days after receiving the submission on December 19, 2008.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number	K083783 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 19, 2008
Decision Date	September 11, 2009
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF