DRAINAGE STENT

Stents, Drains And Dilators For The Biliary Ducts

MICROVASIVE

The following data is part of a premarket notification filed by Microvasive with the FDA for Drainage Stent.

Pre-market Notification Details

Device IDK834468
510k NumberK834468
Device Name:DRAINAGE STENT
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant MICROVASIVE 31 MAPLE ST. Milford,  MA  01757
ContactUnknown Unknown
CorrespondentUnknown Unknown
MICROVASIVE 31 MAPLE ST. Milford,  MA  01757
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-12-20
Decision Date1984-04-20

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