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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 K894924
Device Name 990 GOLD
Applicant
Comprehensive Holistic Dentistry
2006 Broadwway
Boulder,  CO  80302
Applicant Contact STEPHEN KORAL
Correspondent
Comprehensive Holistic Dentistry
2006 Broadwway
Boulder,  CO  80302
Correspondent Contact STEPHEN KORAL
Regulation Number872.3060
Classification Product Code
EJT  
Date Received08/02/1989
Decision Date 10/30/1989
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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