Clearance Summary
MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP received FDA 510(k) clearance under submission number K915353, sponsored by Matrix Medica, 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 1991-12-27.
- Submission: K915353
- Applicant / Sponsor: Matrix Medica, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1991-12-27
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.