Clearance Summary
MEDCOMP GEN III POWER INJECTABLE PORT received FDA 510(k) clearance under submission number K132177, 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 2013-12-12.
- Submission: K132177
- Applicant / Sponsor: Medcomp ( Medical Components)
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 2013-12-12
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.