Clearance Summary
REFLEX(R) ESP received FDA 510(k) clearance under submission number K924881, 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 1993-07-23.
- Submission: K924881
- Applicant / Sponsor: Richard-Allan Medical
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 1993-07-23
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.