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510(k) Premarket Notification Database

Device Classification Name alloy, gold-based noble metal
510(k) NumberK922774
Device NameCOLLEGIATE
Applicant
J.F. JELENKO & CO., INC.
99 business park dr.
armonk,  NY  10504
Contactcostantino volpe
Regulation Number872.3060
Classification Product Code
EJT
Date Received06/09/1992
Decision Date 12/04/1992
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
Statement/Summary/Purged Status Statement only
Type Traditional
Reviewed by Third Party No
Expedited Review

Database Updated 02/06/2009

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