Clearance Summary
LINCOLN MILLS HIP HOLDER received FDA 510(k) clearance under submission number K885215, sponsored by Lincoln Mills, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1989-01-13.
- Submission: K885215
- Applicant / Sponsor: Lincoln Mills, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4950
- Decision date: 1989-01-13
Classification & Regulation
This clearance is catalogued under FDA product code FWZ and 21 CFR 878.4950, within the General, Plastic Surgery review panel as a Class I device.