AD-TECH SUBDURAL ELECTRODE

Electrode, Cortical

AD-TECH MEDICAL INSTRUMENT CORP.

The following data is part of a premarket notification filed by Ad-tech Medical Instrument Corp. with the FDA for Ad-tech Subdural Electrode.

Pre-market Notification Details

Device IDK970587
510k NumberK970587
Device Name:AD-TECH SUBDURAL ELECTRODE
ClassificationElectrode, Cortical
Applicant AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine,  WI  53404 -1876
ContactCurtis Van Allen Ii
CorrespondentCurtis Van Allen Ii
AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine,  WI  53404 -1876
Product CodeGYC  
CFR Regulation Number882.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-18
Decision Date1997-05-09

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