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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 K862754
Device Name CUSTOM IN-THE-EAR AND CANAL HEARING AID
Applicant
Cochlear Laboratories, Ltd.
P.O. Box 20514
Bloomington,  MN  55431
Applicant Contact BRUCE BULLOCK
Correspondent
Cochlear Laboratories, Ltd.
P.O. Box 20514
Bloomington,  MN  55431
Correspondent Contact BRUCE BULLOCK
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/22/1986
Decision Date 08/01/1986
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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