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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 K853381
Device Name OE SERIES OF BEHIND-THE-EAR HEARING AIDS
Applicant
Emtech Laboratories
P.O. Box 12900
Roanoke,  VA  24022
Applicant Contact JERRY AGNEW
Correspondent
Emtech Laboratories
P.O. Box 12900
Roanoke,  VA  24022
Correspondent Contact JERRY AGNEW
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/12/1985
Decision Date 11/08/1985
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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