Clearance Summary
MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE received FDA 510(k) clearance under submission number K883480, sponsored by Site Microsurgical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1988-08-24.
- Submission: K883480
- Applicant / Sponsor: Site Microsurgical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4335
- Decision date: 1988-08-24
Classification & Regulation
This clearance is catalogued under FDA product code FCT and 21 CFR 886.4335, within the Ophthalmic review panel as a Class II device.