NAVARRE PERCUTANEOUS BILIARY DRAINAGE

Stents, Drains And Dilators For The Biliary Ducts

NAVARRE BIOMEDICAL LTD.

The following data is part of a premarket notification filed by Navarre Biomedical Ltd. with the FDA for Navarre Percutaneous Biliary Drainage.

Pre-market Notification Details

Device IDK955110
510k NumberK955110
Device Name:NAVARRE PERCUTANEOUS BILIARY DRAINAGE
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant NAVARRE BIOMEDICAL LTD. 2545 FERNBROOK LN. NORTH Plymouth,  MN  55447
ContactKelly Behrendt
CorrespondentKelly Behrendt
NAVARRE BIOMEDICAL LTD. 2545 FERNBROOK LN. NORTH Plymouth,  MN  55447
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-08
Decision Date1996-11-07
Summary:summary

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