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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hearing aid, group and auditory trainer
510(k) Number K941768
Device Name PHONAK MICROVOX RESONAL FM SYSTEM
Applicant
PHONAK, INC.
850 E. DIEHL RD.
BOX 3117
NAPERVILLE,  IL  60566
Applicant Contact BILL LESIECKI
Correspondent
PHONAK, INC.
850 E. DIEHL RD.
BOX 3117
NAPERVILLE,  IL  60566
Correspondent Contact BILL LESIECKI
Regulation Number874.3320
Classification Product Code
EPF  
Date Received04/11/1994
Decision Date 06/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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