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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 K896157
Device Name DAHLBERG MODEL LH BEHIND-THE-EAR HEARING AID
Applicant
DAHLBERG ELECTRONICS, INC.
225 OSTERMAN DR.
TURTLE LAKE,  WI  54889
Applicant Contact KEVIN L KUTINA
Correspondent
DAHLBERG ELECTRONICS, INC.
225 OSTERMAN DR.
TURTLE LAKE,  WI  54889
Correspondent Contact KEVIN L KUTINA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/24/1989
Decision Date 01/22/1990
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
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