Clearance Summary
FIX-RIGHT 90ML & 180 ML PREFILLED CONT received FDA 510(k) clearance under submission number K811793, sponsored by Richard-Allan Medical Ind., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1981-07-31.
- Submission: K811793
- Applicant / Sponsor: Richard-Allan Medical Ind., Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3250
- Decision date: 1981-07-31
Classification & Regulation
This clearance is catalogued under FDA product code KDT and 21 CFR 864.3250, within the Pathology review panel as a Class I device.