BD PEN NEEDLE

Needle, Hypodermic, Single Lumen

BECTON DICKINSON & CO.

The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Pen Needle.

Pre-market Notification Details

Device IDK131358
510k NumberK131358
Device Name:BD PEN NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant BECTON DICKINSON & CO. 1 BECTON DRIVE MC 372 Franklin Lakes,  NJ  07417 -1885
ContactPasquale Amato
CorrespondentPasquale Amato
BECTON DICKINSON & CO. 1 BECTON DRIVE MC 372 Franklin Lakes,  NJ  07417 -1885
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-10
Decision Date2013-07-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50382903282031 K131358 000
50382903201124 K131358 000
50382903201193 K131358 000
50382903201223 K131358 000
50382903201490 K131358 000
50382903203678 K131358 000
00382903205400 K131358 000
50382903208802 K131358 000
50382903208819 K131358 000
50382903208826 K131358 000
50382903208833 K131358 000
50382903209816 K131358 000
50382903209823 K131358 000
50382903201094 K131358 000

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