Clearance Summary
ROBERTSITE STOPCOCK received FDA 510(k) clearance under submission number K061143, sponsored by Halkey-Roberts Corp.. 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 2006-05-10.
- Submission: K061143
- Applicant / Sponsor: Halkey-Roberts Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2006-05-10
Classification & Regulation
This clearance is catalogued under FDA product code FMG and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.