Clearance Summary
SIAS IRRIGATION/ASPIRATION SYSTEM received FDA 510(k) clearance under submission number K832413, sponsored by Clark Pool & Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1983-10-04.
- Submission: K832413
- Applicant / Sponsor: Clark Pool & Assoc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4670
- Decision date: 1983-10-04
Classification & Regulation
This clearance is catalogued under FDA product code HQC and 21 CFR 886.4670, within the Ophthalmic review panel as a Class II device.