SILASTIC BRAND FOLEY CATHETER

Catheter, Retention Type, Balloon

C.R. BARD, INC.

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

Pre-market Notification Details

Device IDK951103
510k NumberK951103
Device Name:SILASTIC BRAND FOLEY CATHETER
ClassificationCatheter, Retention Type, Balloon
Applicant C.R. BARD, INC. C.R. BARD, INC. 8195 INDUSTRIAL BLVD Covington,  GA  30209
ContactCarol Vierling
CorrespondentCarol Vierling
C.R. BARD, INC. C.R. BARD, INC. 8195 INDUSTRIAL BLVD Covington,  GA  30209
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-10
Decision Date1995-04-28

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