Clearance Summary
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK received FDA 510(k) clearance under submission number K971832, sponsored by M-Pact Worldwide Management Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1997-07-31.
- Submission: K971832
- Applicant / Sponsor: M-Pact Worldwide Management Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4790
- Decision date: 1997-07-31
Classification & Regulation
This clearance is catalogued under FDA product code HOZ and 21 CFR 886.4790, within the Ophthalmic review panel as a Class II device.