BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER

Stents, Drains And Dilators For The Biliary Ducts

PORGES CORP.

The following data is part of a premarket notification filed by Porges Corp. with the FDA for Biliary Endoprosthesis And External Catheter.

Pre-market Notification Details

Device IDK892384
510k NumberK892384
Device Name:BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant PORGES CORP. 5700 WEST 23RD AVE. Gary,  IN  46406
ContactHarry M Kaufman
CorrespondentHarry M Kaufman
PORGES CORP. 5700 WEST 23RD AVE. Gary,  IN  46406
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-06
Decision Date1989-05-04

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