Clearance Summary
PRO-JECT(TM) SAFETY NEEDLE HOLDER received FDA 510(k) clearance under submission number K892665, sponsored by Pro-Tec Containers, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1989-10-04.
- Submission: K892665
- Applicant / Sponsor: Pro-Tec Containers, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 1989-10-04
Classification & Regulation
This clearance is catalogued under FDA product code JKA and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.