BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06)

Electrode, Electrosurgical, Active, Urological

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Coagulating Resector Model (3552xx; Xx=01,02,03,04,05 Or 06).

Pre-market Notification Details

Device IDK962538
510k NumberK962538
Device Name:BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06)
ClassificationElectrode, Electrosurgical, Active, Urological
Applicant C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington,  GA  30014
ContactEvans Yi-wen Wuu
CorrespondentEvans Yi-wen Wuu
C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington,  GA  30014
Product CodeFAS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-28
Decision Date1996-12-17
Summary:summary

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