GOLD CORE 75

Alloy, Gold-based Noble Metal

JENERIC/PENTRON, INC.

The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Gold Core 75.

Pre-market Notification Details

Device IDK993175
510k NumberK993175
Device Name:GOLD CORE 75
ClassificationAlloy, Gold-based Noble Metal
Applicant JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford,  CT  06492 -0724
ContactAnnmarie Tenero
CorrespondentAnnmarie Tenero
JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford,  CT  06492 -0724
Product CodeEJT  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-22
Decision Date1999-10-26
Summary:summary

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