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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 Drive,
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
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