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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 K024136
Device Name AIGIS-SOFT
Applicant
Sb Lucius, Inc.
9778 Katella Ave. Suite 205
Anaheim,  CA  92804
Applicant Contact DAEKYU CHANG
Correspondent
Sb Lucius, Inc.
9778 Katella Ave. Suite 205
Anaheim,  CA  92804
Correspondent Contact DAEKYU CHANG
Regulation Number872.3060
Classification Product Code
EJT  
Date Received12/16/2002
Decision Date 03/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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