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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 K091552
Device Name SWITCH TRT
Applicant
AUDIFON GMBH & CO. KG
403 CHAIRMAN CT.
SUITE 1
DEBARY,  FL  32713
Applicant Contact JANE PERRONE
Correspondent
AUDIFON GMBH & CO. KG
403 CHAIRMAN CT.
SUITE 1
DEBARY,  FL  32713
Correspondent Contact JANE PERRONE
Regulation Number874.3400
Classification Product Code
KLW  
Subsequent Product Code
ESD  
Date Received05/27/2009
Decision Date 08/12/2009
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
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