Clearance Summary
COMBISET OR INFUSION SET received FDA 510(k) clearance under submission number K830868, sponsored by Pan-Tek Intl., Inc.. 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 1983-04-14.
- Submission: K830868
- Applicant / Sponsor: Pan-Tek Intl., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1983-04-14
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.