Clearance Summary
Bonus Therapeutics Mixing and Delivery System received FDA 510(k) clearance under submission number K190996, sponsored by Bonus Therapeutics , 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 2019-07-28.
- Submission: K190996
- Applicant / Sponsor: Bonus Therapeutics , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2019-07-28
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.