Ureteral Dilator Sets, Ureteral Dilators

Dilator, Catheter, Ureteral

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Ureteral Dilator Sets, Ureteral Dilators.

Pre-market Notification Details

Device IDK173654
510k NumberK173654
Device Name:Ureteral Dilator Sets, Ureteral Dilators
ClassificationDilator, Catheter, Ureteral
Applicant Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington,  IN  47404
ContactKotei Aoki
CorrespondentKotei Aoki
Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington,  IN  47404
Product CodeEZN  
CFR Regulation Number876.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-28
Decision Date2018-07-17
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.