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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K844497
Device Name AUSTENAL A-79 CROWN & BRIDGE CASTING ALLOY
Applicant
Austenal Dental, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Applicant Contact ROGER MOLA
Correspondent
Austenal Dental, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Correspondent Contact ROGER MOLA
Regulation Number872.3710
Classification Product Code
EJH  
Date Received11/20/1984
Decision Date 02/27/1985
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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