BD Insulin Syringe

Syringe, Piston

Becton Dickinson And Company

The following data is part of a premarket notification filed by Becton Dickinson And Company with the FDA for Bd Insulin Syringe.

Pre-market Notification Details

Device IDK190054
510k NumberK190054
Device Name:BD Insulin Syringe
ClassificationSyringe, Piston
Applicant Becton Dickinson And Company 1 Becton Drive Franklin Lakes,  NJ  07417
ContactMeriam Youssef
CorrespondentMeriam Youssef
Becton Dickinson And Company 1 Becton Drive Franklin Lakes,  NJ  07417
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-11
Decision Date2019-10-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50382903284400 K190054 000
50382903285094 K190054 000
50382909288563 K190054 000
50382909288532 K190054 000
50382909288549 K190054 000
50382909288556 K190054 000
50382909288518 K190054 000
50382909288501 K190054 000
50382909288570 K190054 000

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