BARD URODYNAMIC CATHETER

Device, Cystometric, Hydraulic

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Urodynamic Catheter.

Pre-market Notification Details

Device IDK924714
510k NumberK924714
Device Name:BARD URODYNAMIC CATHETER
ClassificationDevice, Cystometric, Hydraulic
Applicant C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington,  GA  30014
ContactDonna J Wilson
CorrespondentDonna J Wilson
C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington,  GA  30014
Product CodeFEN  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-21
Decision Date1993-09-21

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