BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55

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 Closed System Transfer Device - P55.

Pre-market Notification Details

Device IDK130197
510k NumberK130197
Device Name:BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55
ClassificationClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Applicant Becton, Dickinson And Company 1 BECTON DRIVE MC237 Franklin Lakes,  NJ  07417
ContactJohn Roberts
CorrespondentJohn Roberts
Becton, Dickinson And Company 1 BECTON DRIVE MC237 Franklin Lakes,  NJ  07417
Product CodeONB  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-28
Decision Date2013-02-27
Summary:summary

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