Cleared Traditional

K050188 - EPIGUARD
(FDA 510(k) Clearance)

K050188 · Episafe Medical Devices, Ltd. · Neurology device

Apr 2005

Decision

90d

Days

Class 2

Risk

K050188 is an FDA 510(k) clearance for the EPIGUARD. This device is classified as a Block, Bite (Class II - Special Controls, product code JXL).

Submitted by Episafe Medical Devices, Ltd. (Somerset, US). The FDA issued a Cleared decision on April 27, 2005, 90 days after receiving the submission on January 27, 2005.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5070.

Submission Details

510(k) Number	K050188 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 27, 2005
Decision Date	April 27, 2005
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF