Clearance Summary
STD MED PRIMO PORT POLY received FDA 510(k) clearance under submission number K080645, sponsored by Std Med, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2008-05-02.
- Submission: K080645
- Applicant / Sponsor: Std Med, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5965
- Decision date: 2008-05-02
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.