Clearance Summary
COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65 received FDA 510(k) clearance under submission number K071821, sponsored by Tonica Elektronik A/S. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2007-07-27.
- Submission: K071821
- Applicant / Sponsor: Tonica Elektronik A/S
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1870
- Decision date: 2007-07-27
Classification & Regulation
This clearance is catalogued under FDA product code GWF and 21 CFR 882.1870, within the Neurology review panel as a Class II device.