ALLROUND 55 LF

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 Allround 55 Lf.

Pre-market Notification Details

Device IDK001260
510k NumberK001260
Device Name:ALLROUND 55 LF
ClassificationAlloy, Gold-based Noble Metal
Applicant J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk,  NY  10504
ContactRaphael Judkins
CorrespondentRaphael Judkins
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 Received2000-04-19
Decision Date2000-05-17

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