Dornier Ureteral Stent

Stent, Ureteral

Dornier MedTech America Inc.

The following data is part of a premarket notification filed by Dornier Medtech America Inc. with the FDA for Dornier Ureteral Stent.

Pre-market Notification Details

Device IDK190312
501k NumberK190312
Device Name:Dornier Ureteral Stent
ClassificationStent, Ureteral
Applicant Dornier MedTech America Inc. 1155 Roberts Blvd, Suite 100 Kennesaw,  GA  30144
ContactJohn Hoffer
CorrespondentJohn Hoffer
Dornier MedTech America Inc. 1155 Roberts Blvd, Suite 100 Kennesaw,  GA  30144
Product CodeFAD  
CFR Regulation Number876.4620 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-12
Decision Date2019-11-15

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