SENORX ES-300

Electrosurgical, Cutting & Coagulation & Accessories

SENORX, INC.

The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Senorx Es-300.

Pre-market Notification Details

Device IDK030473
510k NumberK030473
Device Name:SENORX ES-300
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant SENORX, INC. 11 COLUMBIA, SUITE A Aliso Viejo,  CA  92656
ContactAmy Boucly
CorrespondentDonald James Sherratt
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2003-02-12
Decision Date2003-02-26
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.