ANGIOGRAPHIC FLUSH SYSTEM

Set, Administration, Intravascular

E-Z-EM, INC.

The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Angiographic Flush System.

Pre-market Notification Details

Device IDK914113
510k NumberK914113
Device Name:ANGIOGRAPHIC FLUSH SYSTEM
ClassificationSet, Administration, Intravascular
Applicant E-Z-EM, INC. P.O. BOX 993 266 QUEENSBURY AVENUE Glens Falls,  NY  12801
ContactMerribeth Adams
CorrespondentMerribeth Adams
E-Z-EM, INC. P.O. BOX 993 266 QUEENSBURY AVENUE Glens Falls,  NY  12801
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-13
Decision Date1992-01-22

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