ALLROUND-E (CODE NAME RD 1710)

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 Allround-e (code Name Rd 1710).

Pre-market Notification Details

Device IDK984587
510k NumberK984587
Device Name:ALLROUND-E (CODE NAME RD 1710)
ClassificationAlloy, Other Noble Metal
Applicant J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk,  NY  10504
ContactTridib Dasgupta
CorrespondentTridib Dasgupta
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 Received1998-12-24
Decision Date1999-03-17

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