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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 K130514
Device Name AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT
Applicant
Audifon-USA, Inc.
403 Chairman Ct., Suite 1
Debary,  FL  32713
Applicant Contact JANE E PERRONE
Correspondent
Audifon-USA, Inc.
403 Chairman Ct., Suite 1
Debary,  FL  32713
Correspondent Contact JANE E PERRONE
Regulation Number874.3400
Classification Product Code
KLW  
Subsequent Product Code
ESD  
Date Received02/27/2013
Decision Date 11/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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