Clearance Summary
IOL IMPLANTATION FORCEPS received FDA 510(k) clearance under submission number K883197, sponsored by D & D Surgical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1988-08-22.
- Submission: K883197
- Applicant / Sponsor: D & D Surgical
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1988-08-22
Classification & Regulation
This clearance is catalogued under FDA product code HNR and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.