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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 K083488
Device Name JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT
Applicant
AUDIFON-USA INC.
403 CHAIRMAN CT., STE. 1
DEBARY,  FL  32713
Applicant Contact JANE E PERRONE
Correspondent
AUDIFON-USA INC.
403 CHAIRMAN CT., STE. 1
DEBARY,  FL  32713
Correspondent Contact JANE E PERRONE
Regulation Number874.3400
Classification Product Code
KLW  
Date Received11/25/2008
Decision Date 02/19/2009
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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