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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K954810
Device Name MYERSON IR DENTURE BASE
Applicant
Austenal, Inc.
4101 W. 51st St.
Chicago,  IL  60632
Applicant Contact RONALD DUDEK
Correspondent
Austenal, Inc.
4101 W. 51st St.
Chicago,  IL  60632
Correspondent Contact RONALD DUDEK
Regulation Number872.3760
Classification Product Code
EBI  
Date Received10/19/1995
Decision Date 11/29/1995
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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