Clearance Summary
WYLER SUBDURAL STRIP ELECTRODE received FDA 510(k) clearance under submission number K850342, sponsored by Ad-Tech Medical Instrument Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1985-07-30.
- Submission: K850342
- Applicant / Sponsor: Ad-Tech Medical Instrument Corp
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1310
- Decision date: 1985-07-30
Classification & Regulation
This clearance is catalogued under FDA product code GYC and 21 CFR 882.1310, within the Neurology review panel as a Class II device.