BD Nano 2nd Gen Pen Needle

Needle, Hypodermic, Single Lumen

Becton Dickinson And Company

The following data is part of a premarket notification filed by Becton Dickinson And Company with the FDA for Bd Nano 2nd Gen Pen Needle.

Pre-market Notification Details

Device IDK212015
510k NumberK212015
Device Name:BD Nano 2nd Gen Pen Needle
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Becton Dickinson And Company 1 Becton Drive Franklin Lakes,  NJ  07417
ContactCharlton Foo
CorrespondentCharlton Foo
Becton Dickinson And Company 1 Becton Drive Franklin Lakes,  NJ  07417
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-28
Decision Date2021-11-19

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