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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 K130494
Device Name UNITRON TINNITUS MASKER FEATURE
Applicant
Unitron Hearing
14755 27th Ave. N
Plymouth,  MN  55447
Applicant Contact JIM REITER
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number874.3400
Classification Product Code
KLW  
Date Received02/26/2013
Decision Date 05/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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