Clearance Summary
NEEDLE BENDER TX8225 received FDA 510(k) clearance under submission number K834108, sponsored by Today'S Machining & Design, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1984-03-12.
- Submission: K834108
- Applicant / Sponsor: Today'S Machining & Design, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1984-03-12
Classification & Regulation
This clearance is catalogued under FDA product code LXH and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.