B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE

Needle, Hypodermic, Single Lumen

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for B-d Ultra Fine Ii, Micro Fine + Short Needle Insulin Syringe.

Pre-market Notification Details

Device IDK955235
510k NumberK955235
Device Name:B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes,  NJ  07417 -1880
ContactPetyer Zurlo
CorrespondentPetyer Zurlo
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes,  NJ  07417 -1880
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-14
Decision Date1996-02-12

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