Clearance Summary
Unger Quad Injector received FDA 510(k) clearance under submission number K161483, sponsored by Stradis Healthcare. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2016-10-31.
- Submission: K161483
- Applicant / Sponsor: Stradis Healthcare
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2016-10-31
Classification & Regulation
This clearance is catalogued under FDA product code LCJ , within the Unknown review panel as a device.