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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 K132965
Device Name SOLACE SOUND GENERATORS
Applicant
Amplisound Hearing Products & Services
594 Putnam Rd.
Danielson,  CT  06239
Applicant Contact RALPH T CAMPAGNA
Correspondent
Amplisound Hearing Products & Services
594 Putnam Rd.
Danielson,  CT  06239
Correspondent Contact RALPH T CAMPAGNA
Regulation Number874.3400
Classification Product Code
KLW  
Date Received09/20/2013
Decision Date 03/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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