Clearance Summary
PROCEDURE & RECOVERY PATIENT SUIT received FDA 510(k) clearance under submission number K803171, sponsored by Alba Health Care. 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 1981-03-04.
- Submission: K803171
- Applicant / Sponsor: Alba Health Care
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 1981-03-04
Classification & Regulation
This clearance is catalogued under FDA product code FYB and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.