Clearance Summary
PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE received FDA 510(k) clearance under submission number K983735, sponsored by Pall Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1999-01-07.
- Submission: K983735
- Applicant / Sponsor: Pall Medical
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1999-01-07
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.