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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 K111293
Device Name SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM
Applicant
SOUNDCURE INC
560 SOUTH WINCHESTER BLVD
SUITE 500
SAN JOSE,  CA  95128
Applicant Contact NANCY LINCE
Correspondent
SOUNDCURE INC
560 SOUTH WINCHESTER BLVD
SUITE 500
SAN JOSE,  CA  95128
Correspondent Contact NANCY LINCE
Regulation Number874.3400
Classification Product Code
KLW  
Date Received05/06/2011
Decision Date 08/24/2011
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
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