Clearance Summary
MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU received FDA 510(k) clearance under submission number K790945, sponsored by Vickers America Medical Corp.. 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 1979-06-01.
- Submission: K790945
- Applicant / Sponsor: Vickers America Medical Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1979-06-01
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.