Clearance Summary
AIR LIFT/XEROSTOM ARTIFICIAL SALIVA received FDA 510(k) clearance under submission number K120552, sponsored by Biocosmetics Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2012-06-06.
- Submission: K120552
- Applicant / Sponsor: Biocosmetics Laboratories
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2012-06-06
Classification & Regulation
This clearance is catalogued under FDA product code LFD , within the Unknown review panel as a device.