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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 K880466
Device Name SERIES S415/S425 - BEHIND-THE-EAR HEARING AID
Applicant
Maico Hearing Instruments, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Applicant Contact DUANE SMEDSRUD
Correspondent
Maico Hearing Instruments, Inc.
7375 Bush Lake Rd.
Minneapolis,  MN  55439
Correspondent Contact DUANE SMEDSRUD
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/03/1988
Decision Date 02/23/1988
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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