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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 K891390
Device Name GK ALLOY
Applicant
China Link, Inc.
1720 S. Amphlett Blvd.
Suite 217
San Mateo,  CA  94402
Applicant Contact LORE HARP
Correspondent
China Link, Inc.
1720 S. Amphlett Blvd.
Suite 217
San Mateo,  CA  94402
Correspondent Contact LORE HARP
Regulation Number872.3070
Classification Product Code
EJJ  
Date Received03/14/1989
Decision Date 04/17/1989
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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