URODYNAMIC RECTAL BALLOON

Cystometric Gas (carbon-dioxide) On Hydraulic Device

COOK UROLOGICAL, INC.

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

Pre-market Notification Details

Device IDK912451
510k NumberK912451
Device Name:URODYNAMIC RECTAL BALLOON
ClassificationCystometric Gas (carbon-dioxide) On Hydraulic Device
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 CodeFAP  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-03
Decision Date1991-12-02

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