BD Surgiphor Antimicrobial Irrigation System

Lavage, Jet

Becton, Dickinson And Company

The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Surgiphor Antimicrobial Irrigation System.

Pre-market Notification Details

Device IDK213616
510k NumberK213616
Device Name:BD Surgiphor Antimicrobial Irrigation System
ClassificationLavage, Jet
Applicant Becton, Dickinson And Company 75 N Fairway Dr Vernon Hills,  IL  60061
ContactShelley Wilcox
CorrespondentShelley Wilcox
Becton, Dickinson And Company 75 N Fairway Dr Vernon Hills,  IL  60061
Product CodeFQH  
CFR Regulation Number880.5475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2021-11-15
Decision Date2022-03-23

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