Clearance Summary
AGRAM SPYRAL ELECTRODE received FDA 510(k) clearance under submission number K934779, sponsored by Agram Export-Import 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 1995-03-14.
- Submission: K934779
- Applicant / Sponsor: Agram Export-Import Co.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1350
- Decision date: 1995-03-14
Classification & Regulation
This clearance is catalogued under FDA product code GXZ and 21 CFR 882.1350, within the Neurology review panel as a Class II device.