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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 K964158
Device Name JEL-40 (CODE NAME RD-0430)
Applicant
Jelenko Co.
90 Business Park Dr.
Armonk,  NY  10504
Applicant Contact TRIDIB DASGUPTA
Correspondent
Jelenko Co.
90 Business Park Dr.
Armonk,  NY  10504
Correspondent Contact TRIDIB DASGUPTA
Regulation Number872.3060
Classification Product Code
EJT  
Date Received10/16/1996
Decision Date 12/13/1996
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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