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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 K854311
Device Name EARLENS
Applicant
Sound Acoustic Systems, Ltd.
24861 Alicia Pkwy.
Suite C-302
Laguna,  CA  92653
Applicant Contact LEONARD H COHEN
Correspondent
Sound Acoustic Systems, Ltd.
24861 Alicia Pkwy.
Suite C-302
Laguna,  CA  92653
Correspondent Contact LEONARD H COHEN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/25/1985
Decision Date 04/14/1986
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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