MARDIS DANGLER URETERAL STENT SET

Stent, Ureteral

VAN-TEC, INC.

The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Mardis Dangler Ureteral Stent Set.

Pre-market Notification Details

Device IDK860267
510k NumberK860267
Device Name:MARDIS DANGLER URETERAL STENT SET
ClassificationStent, Ureteral
Applicant VAN-TEC, INC. P.O. BOX 26 Spencer,  IN  47460
ContactJames F Vance
CorrespondentJames F Vance
VAN-TEC, INC. P.O. BOX 26 Spencer,  IN  47460
Product CodeFAD  
CFR Regulation Number876.4620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-27
Decision Date1986-04-03

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