Clearance Summary
OHIO THORACIC SUCTION REGULATOR received FDA 510(k) clearance under submission number K802285, sponsored by Ohio Medical 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 1980-10-03.
- Submission: K802285
- Applicant / Sponsor: Ohio Medical Products
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3450
- Decision date: 1980-10-03
Classification & Regulation
This clearance is catalogued under FDA product code KOP and 21 CFR 872.3450, within the Dental review panel as a Class I device.