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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 K944896
Device Name MATRICS IMPRESSION MATERIAL , SYSTEM
Applicant
Matrics, Inc.
4723 Hiawatha Ave.
Minneapolis,  MN  55406
Applicant Contact RICHARD M USSELMAN
Correspondent
Matrics, Inc.
4723 Hiawatha Ave.
Minneapolis,  MN  55406
Correspondent Contact RICHARD M USSELMAN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/04/1994
Decision Date 02/24/1995
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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