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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 -0124
Applicant Contact DAVID A PREVES, PH.D.
Correspondent
MICRO-EAR TECHNOLOGY, INC.
6222 BURY DR.
P.O. BOX 59124
EDEN PRAIRIE,  MN  55346 -0124
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
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