MIDAS TOUCH ELECTROSURGICAL ELECTRODE

Electrosurgical, Cutting & Coagulation & Accessories

ITI MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Iti Medical Technologies, Inc. with the FDA for Midas Touch Electrosurgical Electrode.

Pre-market Notification Details

Device IDK973234
510k NumberK973234
Device Name:MIDAS TOUCH ELECTROSURGICAL ELECTRODE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ITI MEDICAL TECHNOLOGIES, INC. 2452 ARMSTRONG ST. Livermore,  CA  94550
ContactRoger Werne
CorrespondentRoger Werne
ITI MEDICAL TECHNOLOGIES, INC. 2452 ARMSTRONG ST. Livermore,  CA  94550
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-28
Decision Date1997-10-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30841785106386 K973234 000
30841785106263 K973234 000
30841785106256 K973234 000
30841785106232 K973234 000
30841785106225 K973234 000
30841785106218 K973234 000
30841785106201 K973234 000
30841785106195 K973234 000
30841785106188 K973234 000
30841785106171 K973234 000
30841785106270 K973234 000
30841785106287 K973234 000
30841785106379 K973234 000
30841785106362 K973234 000
30841785106355 K973234 000
30841785106348 K973234 000
30841785106331 K973234 000
30841785106324 K973234 000
30841785106317 K973234 000
30841785106300 K973234 000
30841785106294 K973234 000
30841785106164 K973234 000

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