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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Amalgam
510(k) Number K921538
Device Name AMALGAPHASE
Applicant
Saskan Amalgam Alloys, Inc.
680 N. Lake Shore Dr.
Suite 901
Chicago,  IL  60611
Applicant Contact AN-SHIH CHENG
Correspondent
Saskan Amalgam Alloys, Inc.
680 N. Lake Shore Dr.
Suite 901
Chicago,  IL  60611
Correspondent Contact AN-SHIH CHENG
Regulation Number872.3070
Classification Product Code
EJJ  
Date Received03/31/1992
Decision Date 08/10/1992
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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