PA-400

Alloy, Other 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 Pa-400.

Pre-market Notification Details

Device IDK922449
510k NumberK922449
Device Name:PA-400
ClassificationAlloy, Other Noble Metal
Applicant J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk,  NY  10504
ContactCostantino Volpe
CorrespondentCostantino Volpe
J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk,  NY  10504
Product CodeEJS  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-22
Decision Date1992-08-05

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