Clearance Summary
TELEDYNE DENSCO DRY TIPS SALIVA ABSORB- received FDA 510(k) clearance under submission number K843539, sponsored by Molnlycke A/S Hospital Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1985-05-23.
- Submission: K843539
- Applicant / Sponsor: Molnlycke A/S Hospital Products
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6050
- Decision date: 1985-05-23
Classification & Regulation
This clearance is catalogued under FDA product code EFN and 21 CFR 872.6050, within the Dental review panel as a Class I device.