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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K955509
Device Name MIDAS GOLD ELECTROFORMING SYSTEM
Applicant
Austenal, Inc.
4101 W. 51st St.
Chicago,  IL  60632
Applicant Contact RONALD P DUDEK
Correspondent
Austenal, Inc.
4101 W. 51st St.
Chicago,  IL  60632
Correspondent Contact RONALD P DUDEK
Regulation Number872.3060
Classification Product Code
EJT  
Date Received12/04/1995
Decision Date 12/28/1995
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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