BD U-500 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 U-500 Insulin Syringe.

Pre-market Notification Details

Device IDK151870
510k NumberK151870
Device Name:BD U-500 INSULIN SYRINGE
ClassificationSyringe, Piston
Applicant BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes,  NJ  07666
ContactLuisa F. Metrio
CorrespondentMatthew F. Trachtenberg
BECTON, DICKINSON AND COMPANY 1 BECTON DRIVE Franklin Lakes,  NJ  07666
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-09
Decision Date2016-07-08
Summary:summary

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