IV ADMINISTRATION SET B400 SP

Set, Administration, Intravascular

CODAN US CORP.

The following data is part of a premarket notification filed by Codan Us Corp. with the FDA for Iv Administration Set B400 Sp.

Pre-market Notification Details

Device IDK042693
510k NumberK042693
Device Name:IV ADMINISTRATION SET B400 SP
ClassificationSet, Administration, Intravascular
Applicant CODAN US CORP. 3511 WEST SUNFLOWER AVE. Santa Ana,  CA  92704 -6944
ContactRohit Patel
CorrespondentRohit Patel
CODAN US CORP. 3511 WEST SUNFLOWER AVE. Santa Ana,  CA  92704 -6944
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-30
Decision Date2004-10-21

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