PR CANNULAS

Stents, Drains And Dilators For The Biliary Ducts

OLYMPUS CORP.

The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Pr Cannulas.

Pre-market Notification Details

Device IDK902734
510k NumberK902734
Device Name:PR CANNULAS
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
ContactDaniel Dillon
CorrespondentDaniel Dillon
OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-21
Decision Date1990-08-22

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