BREAST LESION LOCALIZATION NEEDLE

Guide, Needle, Surgical

PROMEDICAL LTD.

The following data is part of a premarket notification filed by Promedical Ltd. with the FDA for Breast Lesion Localization Needle.

Pre-market Notification Details

Device IDK944942
510k NumberK944942
Device Name:BREAST LESION LOCALIZATION NEEDLE
ClassificationGuide, Needle, Surgical
Applicant PROMEDICAL LTD. 240 BRAEN AVE. Wyckoff,  NJ  07481
ContactHenry V Sierakowski
CorrespondentHenry V Sierakowski
PROMEDICAL LTD. 240 BRAEN AVE. Wyckoff,  NJ  07481
Product CodeGDF  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-07
Decision Date1994-11-04

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