TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG

Catheter, Urethral

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Tray, Universal Foly Wo/drainage Bag.

Pre-market Notification Details

Device IDK760253
510k NumberK760253
Device Name:TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG
ClassificationCatheter, Urethral
Applicant C.R. BARD, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGBM  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-07-19
Decision Date1976-08-23

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