SINGLE USE BALLOON DILATOR MAXPASSTM

Stents, Drains And Dilators For The Biliary Ducts

OLYMPUS WINTER & IBE GMBH

The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Single Use Balloon Dilator Maxpasstm.

Pre-market Notification Details

Device IDK050502
510k NumberK050502
Device Name:SINGLE USE BALLOON DILATOR MAXPASSTM
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactLaura Storms-tyler
CorrespondentLaura Storms-tyler
OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-28
Decision Date2005-07-08
Summary:summary

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