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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 K954937
Device Name COAST HEARING CHS (CUSTOM HEARING SYSTEM)
Applicant
Coast Hearing Services
904 SW Bay St.
Newport,  OR  97365
Applicant Contact LE'ANNE MCEACHERN
Correspondent
Coast Hearing Services
904 SW Bay St.
Newport,  OR  97365
Correspondent Contact LE'ANNE MCEACHERN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/08/1995
Decision Date 11/13/1995
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
Predetermined Change
Control Plan Authorized		 No
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