CYSTIC DUCT BALLOON DILATING CATHETER

Stents, Drains And Dilators For The Biliary Ducts

APPLIED MEDICAL RESOURCES

The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Cystic Duct Balloon Dilating Catheter.

Pre-market Notification Details

Device IDK983154
510k NumberK983154
Device Name:CYSTIC DUCT BALLOON DILATING CATHETER
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills,  CA  92653
ContactHoward V Rowe
CorrespondentHoward V Rowe
APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills,  CA  92653
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-09
Decision Date1999-05-05
Summary:summary

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