Clearance Summary
ALTRACLUDE received FDA 510(k) clearance under submission number K811303, sponsored by R&H Medical, 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 1981-06-16.
- Submission: K811303
- Applicant / Sponsor: R&H Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1981-06-16
Classification & Regulation
This clearance is catalogued under FDA product code KDC and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.