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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 K964657
Device Name SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF
Applicant
Micro-Ear Technology, Inc.
3500 Holly Ln. N., #10
Plymouth,  MN  55447
Applicant Contact DAVID PREVES
Correspondent
Micro-Ear Technology, Inc.
3500 Holly Ln. N., #10
Plymouth,  MN  55447
Correspondent Contact DAVID PREVES
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/20/1996
Decision Date 02/11/1997
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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