Clearance Summary
Caphosol Artifical Saliva Tablets received FDA 510(k) clearance under submission number K162167, sponsored by Eusa Pharma (Uk) Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2017-03-31.
- Submission: K162167
- Applicant / Sponsor: Eusa Pharma (Uk) Limited
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2017-03-31
Classification & Regulation
This clearance is catalogued under FDA product code LFD , within the Unknown review panel as a device.