EUREKA PLUS

Alloy, Gold-based Noble Metal

J.F. JELENKO & CO., INC.

The following data is part of a premarket notification filed by J.f. Jelenko & Co., Inc. with the FDA for Eureka Plus.

Pre-market Notification Details

Device IDK944887
510k NumberK944887
Device Name:EUREKA PLUS
ClassificationAlloy, Gold-based Noble Metal
Applicant J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk,  NY  10504
ContactPaul J Cascone
CorrespondentPaul J Cascone
J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk,  NY  10504
Product CodeEJT  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-04
Decision Date1994-11-07

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