Magic3 Go Intermittent Urinary Catheter

Catheter, Straight

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Magic3 Go Intermittent Urinary Catheter.

Pre-market Notification Details

Device IDK150345
510k NumberK150345
Device Name:Magic3 Go Intermittent Urinary Catheter
ClassificationCatheter, Straight
Applicant C.R. BARD, INC. 8195 INDUSTRIAL BLVD Covington,  GA  30014
ContactWilliam Heard
CorrespondentWilliam Heard
C.R. BARD, INC. 8195 INDUSTRIAL BLVD Covington,  GA  30014
Product CodeEZD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-11
Decision Date2015-05-11
Summary:summary

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