Clearance Summary
COVER, SHOE OPERATING ROOM received FDA 510(k) clearance under submission number K865023, sponsored by Ulti-Med Intl., 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 1987-01-12.
- Submission: K865023
- Applicant / Sponsor: Ulti-Med Intl., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1987-01-12
Classification & Regulation
This clearance is catalogued under FDA product code FXP and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.