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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 K854315
Device Name HEARTECH MODEL IN TECH
Applicant
HEARING TECH, INC.
5600 ROWLAND RD.
SUITE 250
MINNETONKA,  MN  55343
Applicant Contact THOMAS P HUBER
Correspondent
HEARING TECH, INC.
5600 ROWLAND RD.
SUITE 250
MINNETONKA,  MN  55343
Correspondent Contact THOMAS P HUBER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/28/1985
Decision Date 01/21/1986
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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