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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 K871205
Device Name CUSTOM IN-THE-EAR HEARING AID
Applicant
Audiological Services, Inc.
P.O. Box 1309
Hagerstown,  MD  21741
Applicant Contact GEORGE KALIN
Correspondent
Audiological Services, Inc.
P.O. Box 1309
Hagerstown,  MD  21741
Correspondent Contact GEORGE KALIN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/25/1987
Decision Date 04/07/1987
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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