Clearance Summary
OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT received FDA 510(k) clearance under submission number K801641, sponsored by Ohio Medical Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1980-07-28.
- Submission: K801641
- Applicant / Sponsor: Ohio Medical Products
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4420
- Decision date: 1980-07-28
Classification & Regulation
This clearance is catalogued under FDA product code DTS and 21 CFR 870.4420, within the Cardiovascular review panel as a Class II device.