Clearance Summary
INVIRO SYRINGE received FDA 510(k) clearance under submission number K941450, sponsored by Dr. F. Ross Sharp , 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 1994-12-12.
- Submission: K941450
- Applicant / Sponsor: Dr. F. Ross Sharp , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1994-12-12
Classification & Regulation
This clearance is catalogued under FDA product code MEG and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.