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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 K923640
Device Name GK DENTAL AMALGAM ALLOY
Applicant
The Patron Trading Corp.
75 - 03 37th Ave.
Jackson Heights,  NY  11372
Applicant Contact HSIANG-LUN CHEN
Correspondent
The Patron Trading Corp.
75 - 03 37th Ave.
Jackson Heights,  NY  11372
Correspondent Contact HSIANG-LUN CHEN
Regulation Number872.3070
Classification Product Code
EJJ  
Date Received07/21/1992
Decision Date 02/12/1993
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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