JEL BIOS 18 (CODE NAME RD- 1214)

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 Jel Bios 18 (code Name Rd- 1214).

Pre-market Notification Details

Device IDK993152
510k NumberK993152
Device Name:JEL BIOS 18 (CODE NAME RD- 1214)
ClassificationAlloy, Gold-based 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 CodeEJT  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-21
Decision Date1999-10-21

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