WYLER SUBDURAL STRIP 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 Wyler Subdural Strip Electrode.

Pre-market Notification Details

Device IDK850342
510k NumberK850342
Device Name:WYLER SUBDURAL STRIP ELECTRODE
ClassificationElectrode, Cortical
Applicant AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine,  WI  53404 -1876
ContactDavid A Putz
CorrespondentDavid A Putz
AD-TECH MEDICAL INSTRUMENT CORP. 1901 WILLIAM ST. Racine,  WI  53404 -1876
Product CodeGYC  
CFR Regulation Number882.1310 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-28
Decision Date1985-07-30

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