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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 K964216
Device Name STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER
Applicant
Starkey Laboratories, Inc.
6600-6700 Washington Ave.South
Eden Prairie,  MN  55344
Applicant Contact SHARI L SWIDEN
Correspondent
Starkey Laboratories, Inc.
6600-6700 Washington Ave.South
Eden Prairie,  MN  55344
Correspondent Contact SHARI L SWIDEN
Regulation Number874.3400
Classification Product Code
KLW  
Date Received10/22/1996
Decision Date 12/06/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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