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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 K010416
Device Name HERACERAM 75
Applicant
Jelenko Co.
99 Business Park Dr.
Armonk,  NY  10504
Applicant Contact RAPHAEL JUDKINS
Correspondent
Jelenko Co.
99 Business Park Dr.
Armonk,  NY  10504
Correspondent Contact RAPHAEL JUDKINS
Regulation Number872.3060
Classification Product Code
EJT  
Date Received02/12/2001
Decision Date 03/08/2001
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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