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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 K961653
Device Name PHONAK SONA P2
Applicant
Phonak, Inc.
850 E. Diehl Rd.
P.O. Box 3017
Naperville,  IL  60566
Applicant Contact FRANCIS KUK, PH.D.
Correspondent
Phonak, Inc.
850 E. Diehl Rd.
P.O. Box 3017
Naperville,  IL  60566
Correspondent Contact FRANCIS KUK, PH.D.
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/30/1996
Decision Date 05/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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