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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Masker, Tinnitus
510(k) Number K030180
Device Name CRESCENT TINNITUS RETAINING SOUND GENERATOR
Applicant
STARKEY LABORATORIES, INC.
6700 WASHINGTON AVE. SOUTH
EDEN PRAIRIE,  MN  55344
Applicant Contact SCOTT LAPOINTE
Correspondent
STARKEY LABORATORIES, INC.
6700 WASHINGTON AVE. SOUTH
EDEN PRAIRIE,  MN  55344
Correspondent Contact SCOTT LAPOINTE
Regulation Number874.3400
Classification Product Code
KLW  
Date Received01/17/2003
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
Predetermined Change
Control Plan Authorized		 No
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