Cleared Traditional

CRESCENT TINNITUS RETAINING SOUND GENERATOR

K030180 · Starkey Laboratories, Inc. · Ear, Nose, Throat

Sep 2003

Decision

243d

Days

Class 2

Risk

About This 510(k) Submission

K030180 is an FDA 510(k) clearance for the CRESCENT TINNITUS RETAINING SOUND GENERATOR, a Masker, Tinnitus (Class II — Special Controls, product code KLW), submitted by Starkey Laboratories, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on September 17, 2003, 243 days after receiving the submission on January 17, 2003. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number	K030180 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 2003
Decision Date	September 17, 2003
Days to Decision	243 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement