Clearance Summary
ROBERTSITE VIAL ADAPTER, MODEL 245700021 received FDA 510(k) clearance under submission number K040634, 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 2004-03-23.
- Submission: K040634
- Applicant / Sponsor: Halkey-Roberts Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2004-03-23
Classification & Regulation
This clearance is catalogued under FDA product code LHI and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.