Clearance Summary
HIGH VAC received FDA 510(k) clearance under submission number K920492, sponsored by Hygoplastic, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1992-05-11.
- Submission: K920492
- Applicant / Sponsor: Hygoplastic, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1992-05-11
Classification & Regulation
This clearance is catalogued under FDA product code DYN and 21 CFR 872.6640, within the Dental review panel as a Class I device.