BD Eclipse Hypodermic 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 Eclipse Hypodermic Needle.

Pre-market Notification Details

Device IDK161170
510k NumberK161170
Device Name:BD Eclipse Hypodermic Needle
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Becton, Dickinson And Company 1 Becton Drive Franklin Lakes,  NJ  07417
ContactPriyanka Apte
CorrespondentPriyanka Apte
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 Received2016-04-26
Decision Date2016-05-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382903057772 K161170 000
50382903033213 K161170 000
30382903033066 K161170 000
30382903033073 K161170 000
00382903057122 K161170 000
00382903058266 K161170 000
30382903058298 K161170 000
00382903058372 K161170 000
00382903058389 K161170 000
50382903033046 K161170 000
50382903032780 K161170 000

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