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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K893219
Device Name MATRX DENTAL UNIT
Applicant
Matrix Medica, Inc.
145 Mid County Dr.
Orchard Park,  NY 
Applicant Contact WYNNE, P.E.
Correspondent
Matrix Medica, Inc.
145 Mid County Dr.
Orchard Park,  NY 
Correspondent Contact WYNNE, P.E.
Regulation Number872.6640
Classification Product Code
EIA  
Date Received04/27/1989
Decision Date 08/07/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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