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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 K920657
Device Name DI CUSTOM IN THE EAR AND IN THE CANAL
Applicant
DAKOTA LABORATORIES, INC.
P.O. BOX 8
LAKE ANDES,  SD  57356
Applicant Contact DON TRUMMER
Correspondent
DAKOTA LABORATORIES, INC.
P.O. BOX 8
LAKE ANDES,  SD  57356
Correspondent Contact DON TRUMMER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/12/1992
Decision Date 03/31/1992
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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