Clearance Summary
HENKE-JECT PRESSURE SYRINGE (MODIFICATION) received FDA 510(k) clearance under submission number K864294, sponsored by Smith & Nephew, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1987-11-04.
- Submission: K864294
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4475
- Decision date: 1987-11-04
Classification & Regulation
This clearance is catalogued under FDA product code EGM and 21 CFR 872.4475, within the Dental review panel as a Class II device.