MIDAS TOUCH BIPOLAR FORCEPS

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 Bipolar Forceps.

Pre-market Notification Details

Device IDK982705
510k NumberK982705
Device Name:MIDAS TOUCH BIPOLAR FORCEPS
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 Received1998-08-03
Decision Date1998-09-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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