Clearance Summary
ACE-KYLE DYE INJECTION NEEDLE P/N 14082 received FDA 510(k) clearance under submission number K853604, sponsored by Today'S Machining & Design, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1985-11-12.
- Submission: K853604
- Applicant / Sponsor: Today'S Machining & Design, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1985-11-12
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.