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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 K903583
Device Name SERIES MCAXX (MODEL 851) ITE HEARING AID
Applicant
Maico Hearing Instruments, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439 -2029
Applicant Contact DIANNE TARTER
Correspondent
Maico Hearing Instruments, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439 -2029
Correspondent Contact DIANNE TARTER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/08/1990
Decision Date 10/09/1990
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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