Clearance Summary
PLAK VAK - PV-10 received FDA 510(k) clearance under submission number K864540, sponsored by Paul S. Barclay, D.D.S. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1987-07-02.
- Submission: K864540
- Applicant / Sponsor: Paul S. Barclay, D.D.S. , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6510
- Decision date: 1987-07-02
Classification & Regulation
This clearance is catalogued under FDA product code EFS and 21 CFR 872.6510, within the Dental review panel as a Class I device.