Clearance Summary
MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE received FDA 510(k) clearance under submission number K013875, sponsored by Med-Tec,Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2002-09-27.
- Submission: K013875
- Applicant / Sponsor: Med-Tec,Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5710
- Decision date: 2002-09-27
Classification & Regulation
This clearance is catalogued under FDA product code IXI and 21 CFR 892.5710, within the Radiology review panel as a Class II device.