NIR BILIARY STENT

Stents, Drains And Dilators For The Biliary Ducts

MEDINOL LTD.

The following data is part of a premarket notification filed by Medinol Ltd. with the FDA for Nir Biliary Stent.

Pre-market Notification Details

Device IDK002130
510k NumberK002130
Device Name:NIR BILIARY STENT
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant MEDINOL LTD. KIRYAT ATIDIM, BUILDING 7 ENTRANCE A, 5TH FL., POB 58165 Tel-aviv,  IL 61581
ContactNasr Salman
CorrespondentNasr Salman
MEDINOL LTD. KIRYAT ATIDIM, BUILDING 7 ENTRANCE A, 5TH FL., POB 58165 Tel-aviv,  IL 61581
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-14
Decision Date2000-10-30

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