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 IDK213156
510k NumberK213156
Device Name:BD Nano 2nd Gen Pen Needle
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Becton, Dickinson And Company 1 Becton Drive Franklin Lakes,  NJ  07417
ContactMark William
CorrespondentMark William
Becton, Dickinson And Company 1 Becton Drive Franklin Lakes,  NJ  07417
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-20
Decision Date2021-12-08

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