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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 K872348
Device Name HEARING AID
Applicant
ASSURED SOUND LABORATORIES, INC.
7100 BROADWAY
#3APH
DENVER,  CO  80221
Applicant Contact DAVID L MEDOW
Correspondent
ASSURED SOUND LABORATORIES, INC.
7100 BROADWAY
#3APH
DENVER,  CO  80221
Correspondent Contact DAVID L MEDOW
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/17/1987
Decision Date 07/31/1987
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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