BARD LATEX URINARY CATHETERS

Catheter, Urological

C.R. BARD, INC.

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

Pre-market Notification Details

Device IDK922431
510k NumberK922431
Device Name:BARD LATEX URINARY CATHETERS
ClassificationCatheter, Urological
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 CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-22
Decision Date1993-03-25

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