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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 K870982
Device Name HEARING AID
Applicant
Audioear Electronics
Box 159, Hwy. Bus. 60 W.
Dexter,  MO  63841
Applicant Contact LARRY WARREN
Correspondent
Audioear Electronics
Box 159, Hwy. Bus. 60 W.
Dexter,  MO  63841
Correspondent Contact LARRY WARREN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/10/1987
Decision Date 03/30/1987
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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