Clearance Summary
MED-LOK received FDA 510(k) clearance under submission number K093176, sponsored by Sta-Med, LLC. 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 2010-04-06.
- Submission: K093176
- Applicant / Sponsor: Sta-Med, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2010-04-06
Classification & Regulation
This clearance is catalogued under FDA product code MEG and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.