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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 K962847
Device Name MT10P, MT60-PP, MT60-AGC0, AND MT60
Applicant
Micro-Tech Hearing Instruments
P.O. Box 59124
Minneapolis,  MN  55459
Applicant Contact DAVID A PREVES
Correspondent
Micro-Tech Hearing Instruments
P.O. Box 59124
Minneapolis,  MN  55459
Correspondent Contact DAVID A PREVES
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/22/1996
Decision Date 08/09/1996
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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