KSEA BIPOLAR ELECTROTOME

Electrode, Electrosurgical, Active, Urological

KSEA

The following data is part of a premarket notification filed by Ksea with the FDA for Ksea Bipolar Electrotome.

Pre-market Notification Details

Device IDK061541
510k NumberK061541
Device Name:KSEA BIPOLAR ELECTROTOME
ClassificationElectrode, Electrosurgical, Active, Urological
Applicant KSEA 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactJames A Lee
CorrespondentJames A Lee
KSEA 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeFAS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-05
Decision Date2006-08-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551075623 K061541 000
04048551274170 K061541 000
04048551274156 K061541 000
04048551274132 K061541 000
04048551274118 K061541 000

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