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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 K941734
Device Name PHONAK SONO-FORTE 331X BTE HEARING INSTRUMENTS
Applicant
Phonak, Inc.
850 E. Diehl Rd.
Naperville,  IL  60563
Applicant Contact BILL LESIECKI
Correspondent
Phonak, Inc.
850 E. Diehl Rd.
Naperville,  IL  60563
Correspondent Contact BILL LESIECKI
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/07/1994
Decision Date 05/13/1994
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
Predetermined Change
Control Plan Authorized		 No
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