BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET

Catheter, Nephrostomy

COOK UROLOGICAL, INC.

The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Balloon (nephrostomy Tract) Dilation Catheter Set.

Pre-market Notification Details

Device IDK891406
510k NumberK891406
Device Name:BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET
ClassificationCatheter, Nephrostomy
Applicant COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer,  IN  47460
ContactMichelle Young
CorrespondentMichelle Young
COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer,  IN  47460
Product CodeLJE  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-14
Decision Date1989-04-07

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