0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

BD

The following data is part of a premarket notification filed by Bd with the FDA for 0.9% Sodium Chloride Injection, Usp Bd Pre-filled Flush Syringe.

Pre-market Notification Details

Device IDK011982
510k NumberK011982
Device Name:0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant BD ONE BECTON DRIVE MC226 Franklin Lakes,  NJ  07417
ContactGregory W Morgan
CorrespondentGregory W Morgan
BD ONE BECTON DRIVE MC226 Franklin Lakes,  NJ  07417
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-26
Decision Date2001-07-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50382903065191 K011982 000
50382903065245 K011982 000
50382903065009 K011982 000
50382903065023 K011982 000
50382903065030 K011982 000
50382903065047 K011982 000
50382903065054 K011982 000
50382903065078 K011982 000
50382903065085 K011982 000
50382903065184 K011982 000
50382903065221 K011982 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.