CRESCENT TINNITUS RETAINING SOUND GENERATOR


Device Classification Name

masker, tinnitus

510(k) Number K030180
Device Name CRESCENT TINNITUS RETAINING SOUND GENERATOR
Original Applicant
STARKEY LABORATORIES, INC.
6700 washington ave. south
eden prairie, 
MN 
55344

Original Contact scott lapointe
Regulation Number 874.3400
Classification Product Code
KLW  
Date Received 01/17/2003
Decision Date 09/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No