MICROGUIDE LESION MARKING SYSTEM

Guide, Needle, Surgical

ANGIODYNAMICS, DIV. E-Z-EM, INC.

The following data is part of a premarket notification filed by Angiodynamics, Div. E-z-em, Inc. with the FDA for Microguide Lesion Marking System.

Pre-market Notification Details

Device IDK923120
510k NumberK923120
Device Name:MICROGUIDE LESION MARKING SYSTEM
ClassificationGuide, Needle, Surgical
Applicant ANGIODYNAMICS, DIV. E-Z-EM, INC. P.O. 993 635 BIG BOOM ROAD Glens Falls,  NY  12801
ContactMarlene Wright
CorrespondentMarlene Wright
ANGIODYNAMICS, DIV. E-Z-EM, INC. P.O. 993 635 BIG BOOM ROAD Glens Falls,  NY  12801
Product CodeGDF  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-26
Decision Date1992-09-01

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