Cleared Traditional

K111555 - CIRCUMAURAL ADHESIVE REPLACEMENT
(FDA 510(k) Clearance)

K111555 · R & D Medical Products, Inc. · Neurology device

Jul 2011

Decision

52d

Days

Class 2

Risk

K111555 is an FDA 510(k) clearance for the CIRCUMAURAL ADHESIVE REPLACEMENT. This device is classified as a Stimulator, Auditory, Evoked Response (Class II - Special Controls, product code GWJ).

Submitted by R & D Medical Products, Inc. (Lake Forest, US). The FDA issued a Cleared decision on July 25, 2011, 52 days after receiving the submission on June 3, 2011.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number	K111555 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 03, 2011
Decision Date	July 25, 2011
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF