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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 K993136
Device Name JEL BIOS 10 (CODE NAME RD-1801)
Applicant
J.F. Jelenko & Co., Inc.
99 Business Park Dr.
Armonk,  NY  10504
Applicant Contact TRIDIB R DASGUPTA
Correspondent
J.F. Jelenko & Co., Inc.
99 Business Park Dr.
Armonk,  NY  10504
Correspondent Contact TRIDIB R DASGUPTA
Regulation Number872.3060
Classification Product Code
EJT  
Date Received09/20/1999
Decision Date 10/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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