Clearance Summary
Dignity Dual Port received FDA 510(k) clearance under submission number K153238, sponsored by Medcomp ( Medical Components). 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 2016-03-15.
- Submission: K153238
- Applicant / Sponsor: Medcomp ( Medical Components)
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 2016-03-15
Classification & Regulation
This clearance is catalogued under FDA product code LJT and 21 CFR 880.5965, within the General Hospital review panel as a Class II device.