Clearance Summary
TEN20 CONDUCTIVE received FDA 510(k) clearance under submission number K883149, sponsored by Weaver & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1988-09-28.
- Submission: K883149
- Applicant / Sponsor: Weaver & Co.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1275
- Decision date: 1988-09-28
Classification & Regulation
This clearance is catalogued under FDA product code GYB and 21 CFR 882.1275, within the Neurology review panel as a Class II device.