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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 K873003
Device Name HEARING AID (ALL-IN-THE-EAR)
Applicant
ACOUSTICAL HEARING SERVICES, INC.
225 SECOND AVE.
WARREN,  PA  16365
Applicant Contact TOM MINGO
Correspondent
ACOUSTICAL HEARING SERVICES, INC.
225 SECOND AVE.
WARREN,  PA  16365
Correspondent Contact TOM MINGO
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/04/1987
Decision Date 12/08/1987
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
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