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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 K911211
Device Name PHONAK 9100 SC-AF ITE HEARING INSTRUMENT
Applicant
Phonak, Inc.
850 E. Diehl Rd.
P.O. Box 3017
Naperville,  IL  60566
Applicant Contact BILL LESIECKI
Correspondent
Phonak, Inc.
850 E. Diehl Rd.
P.O. Box 3017
Naperville,  IL  60566
Correspondent Contact BILL LESIECKI
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/19/1991
Decision Date 04/17/1991
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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