Clearance Summary
VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000 received FDA 510(k) clearance under submission number K984270, sponsored by Roger L. Goodman, D.D.S., P.C.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1999-05-20.
- Submission: K984270
- Applicant / Sponsor: Roger L. Goodman, D.D.S., P.C.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6885
- Decision date: 1999-05-20
Classification & Regulation
This clearance is catalogued under FDA product code MED and 21 CFR 880.6885, within the General Hospital review panel as a Class II device.