BECTON DICKINSON SYRINGES

Syringe, Piston

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 Becton Dickinson Syringes.

Pre-market Notification Details

Device IDK980580
510k NumberK980580
Device Name:BECTON DICKINSON SYRINGES
ClassificationSyringe, Piston
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes,  NJ  07417 -1880
ContactPeter Zurio
CorrespondentPeter Zurio
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes,  NJ  07417 -1880
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-17
Decision Date1998-06-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382903033448 K980580 000

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