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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 K970880
Device Name POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN
Applicant
Micro-Ear Technology, Inc.
6222 Bury Dr.
P.O. Box 59124
Eden Prairie,  MN  55346
Applicant Contact DAVID A PREVES, PH.D.
Correspondent
Micro-Ear Technology, Inc.
6222 Bury Dr.
P.O. Box 59124
Eden Prairie,  MN  55346
Correspondent Contact DAVID A PREVES, PH.D.
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/10/1997
Decision Date 06/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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