BIOPSY NEEDLE GUIDE ATTACHMENT

Transducer, Ultrasonic, Obstetric

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 IDK863797
510k NumberK863797
Device Name:BIOPSY NEEDLE GUIDE ATTACHMENT
ClassificationTransducer, Ultrasonic, Obstetric
Applicant ELSCINT, INC. 751 EXPRESSWAY DR. Itasca,  IL  60143
ContactRobert E Kenney
CorrespondentRobert E Kenney
ELSCINT, INC. 751 EXPRESSWAY DR. Itasca,  IL  60143
Product CodeHGL  
CFR Regulation Number884.2960 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-29
Decision Date1987-03-27

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