DISPOSABLE BIPOLAR ELECTRODE

Electrosurgical, Cutting & Coagulation & Accessories

NEURO NAVIGATIONAL CORP.

The following data is part of a premarket notification filed by Neuro Navigational Corp. with the FDA for Disposable Bipolar Electrode.

Pre-market Notification Details

Device IDK952832
510k NumberK952832
Device Name:DISPOSABLE BIPOLAR ELECTRODE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant NEURO NAVIGATIONAL CORP. 3180 PULLMAN ST. Costa Mesa,  CA  92626
ContactKaren U Salinas
CorrespondentKaren U Salinas
NEURO NAVIGATIONAL CORP. 3180 PULLMAN ST. Costa Mesa,  CA  92626
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-20
Decision Date1995-07-26

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