Clearance Summary
BOWRON received FDA 510(k) clearance under submission number K922618, sponsored by G.L. Bowron & Co. , Ltd.. 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 1993-08-19.
- Submission: K922618
- Applicant / Sponsor: G.L. Bowron & Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5400
- Decision date: 1993-08-19
Classification & Regulation
This clearance is catalogued under FDA product code FMZ and 21 CFR 880.5400, within the General Hospital review panel as a Class II device.