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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 K862768
Device Name FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10
Applicant
Maico Hearing Instruments, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439 -2029
Applicant Contact PAUL M D'AMICO
Correspondent
Maico Hearing Instruments, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439 -2029
Correspondent Contact PAUL M D'AMICO
Regulation Number874.3300
Classification Product Code
LRB  
Date Received07/22/1986
Decision Date 08/13/1986
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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