URETERAL CATHETER

Catheter, Ureteral, Gastro-urology

COOK UROLOGICAL, INC.

The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Ureteral Catheter.

Pre-market Notification Details

Device IDK923729
510k NumberK923729
Device Name:URETERAL CATHETER
ClassificationCatheter, Ureteral, Gastro-urology
Applicant COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer,  IN  47460
ContactTammy Bacon
CorrespondentTammy Bacon
COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer,  IN  47460
Product CodeEYB  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-27
Decision Date1993-12-07

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