Clearance Summary
PARKE-DAVIS TOTAL HIP PROSTHESIS received FDA 510(k) clearance under submission number K791875, sponsored by Warner-Lambert Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1979-10-04.
- Submission: K791875
- Applicant / Sponsor: Warner-Lambert Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 1979-10-04
Classification & Regulation
This clearance is catalogued under FDA product code DXQ and 21 CFR 870.1120, within the Cardiovascular review panel as a Class II device.