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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 K971845
Device Name HEARTLAND TECHNOLOGIES, ITE, ITC, CIC
Applicant
Sound Hearing Instruments, Inc.
4808 Nicollet Ave. So.
Minneapolis,  MN  55409
Applicant Contact DALE WOODARD
Correspondent
Sound Hearing Instruments, Inc.
4808 Nicollet Ave. So.
Minneapolis,  MN  55409
Correspondent Contact DALE WOODARD
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/19/1997
Decision Date 08/15/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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