BARD MALE EXTERNAL CATHETER

Collector, Urine, (and Accessories) For Indwelling Catheter

C.R. BARD, INC.

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

Pre-market Notification Details

Device IDK802433
510k NumberK802433
Device Name:BARD MALE EXTERNAL CATHETER
ClassificationCollector, Urine, (and Accessories) For Indwelling Catheter
Applicant C.R. BARD, INC. 110 MARSHALL DRIVE Warrandale,  PA  15086
Product CodeKNX  
CFR Regulation Number876.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-06
Decision Date1980-10-31

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