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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, air-conduction, prescription
510(k) Number K950758
Device Name DYNA 231X
Applicant
PHONAK, INC.
850 EAST DIEHL RD.
P.O. BOX 3017
NAPERVILLE,  IL  60566
Applicant Contact WILLIAM LESIECKI
Correspondent
PHONAK, INC.
850 EAST DIEHL RD.
P.O. BOX 3017
NAPERVILLE,  IL  60566
Correspondent Contact WILLIAM LESIECKI
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/17/1995
Decision Date 03/21/1995
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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