BD PhaSeal Optima Closed System Drug Transfer Device

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Becton, Dickinson And Company

The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Phaseal Optima Closed System Drug Transfer Device.

Pre-market Notification Details

Device IDK201099
510k NumberK201099
Device Name:BD PhaSeal Optima Closed System Drug Transfer Device
ClassificationClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Applicant Becton, Dickinson And Company 1 Becton Drive Franklin Lakes,  NJ  07417
ContactAmy Honey
CorrespondentAmy Honey
Becton, Dickinson And Company 1 Becton Drive Franklin Lakes,  NJ  07417
Product CodeONB  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-24
Decision Date2020-08-12

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