BARD MALECOT AND PEZZER DRAINS

Catheter, Malecot

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Malecot And Pezzer Drains.

Pre-market Notification Details

Device IDK070879
510k NumberK070879
Device Name:BARD MALECOT AND PEZZER DRAINS
ClassificationCatheter, Malecot
Applicant C.R. BARD, INC. 13183 HARLAND DRIVE Covington,  GA  30014 -6421
ContactJohn Knorpp
CorrespondentJohn Knorpp
C.R. BARD, INC. 13183 HARLAND DRIVE Covington,  GA  30014 -6421
Product CodeFEW  
CFR Regulation Number876.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-30
Decision Date2007-04-24
Summary:summary

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