BIOPSY NEEDLE GUIDE ATTACHMENT

Biopsy Needle

ELSCINT, INC.

The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Biopsy Needle Guide Attachment.

Pre-market Notification Details

Device IDK890327
510k NumberK890327
Device Name:BIOPSY NEEDLE GUIDE ATTACHMENT
ClassificationBiopsy Needle
Applicant ELSCINT, INC. 751 EXPRESSWAY DR. Itasca,  IL  60143
ContactRobert E Kenney
CorrespondentRobert E Kenney
ELSCINT, INC. 751 EXPRESSWAY DR. Itasca,  IL  60143
Product CodeFCG  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-23
Decision Date1989-03-08

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