Clearance Summary
KIT,I.V. START received FDA 510(k) clearance under submission number K940035, sponsored by Mason-Keller 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 1994-06-03.
- Submission: K940035
- Applicant / Sponsor: Mason-Keller Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1994-06-03
Classification & Regulation
This clearance is catalogued under FDA product code LYZ and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.