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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Face Plate Hearing Aid
510(k) Number K871884
Device Name IN THE EAR & IN THE CANAL HEARING AID FACE PLATE
Applicant
Hearing Services, Inc.
7480 Washington Ave. S
Eden Prairie,  MN  55344
Applicant Contact MICHAEL M WINSHIP
Correspondent
Hearing Services, Inc.
7480 Washington Ave. S
Eden Prairie,  MN  55344
Correspondent Contact MICHAEL M WINSHIP
Regulation Number874.3300
Classification Product Code
LRB  
Date Received05/13/1987
Decision Date 10/27/1987
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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