Clearance Summary
BRADBURY INTRAOCULAR RETINAL KIT CAT #200 received FDA 510(k) clearance under submission number K881049, sponsored by Microline Pentax, 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 1988-09-12.
- Submission: K881049
- Applicant / Sponsor: Microline Pentax, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1988-09-12
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.