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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 K896915
Device Name PALLADIUM BASED DENTAL ALLOY FOR PORCELAIN-METAL
Applicant
Jelenko Co.
90 Business Park Dr.
Armonk,  NY  10504
Applicant Contact MARCY KRAMER
Correspondent
Jelenko Co.
90 Business Park Dr.
Armonk,  NY  10504
Correspondent Contact MARCY KRAMER
Regulation Number872.3060
Classification Product Code
EJT  
Date Received12/11/1989
Decision Date 04/30/1990
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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