NEYORO 65CF

Alloy, Gold-based Noble Metal

DERINGER-NEY INC.

The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Neyoro 65cf.

Pre-market Notification Details

Device IDK890569
510k NumberK890569
Device Name:NEYORO 65CF
ClassificationAlloy, Gold-based Noble Metal
Applicant DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield,  CT  06002
ContactJohn M Kuzmech
CorrespondentJohn M Kuzmech
DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield,  CT  06002
Product CodeEJT  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-06
Decision Date1989-03-09

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