Clearance Summary
REFLEX(R) ECA received FDA 510(k) clearance under submission number K924929, sponsored by Richard-Allan Medical. 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 1993-07-21.
- Submission: K924929
- Applicant / Sponsor: Richard-Allan Medical
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1993-07-21
Classification & Regulation
This clearance is catalogued under FDA product code HBT and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.