Clearance Summary
INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. received FDA 510(k) clearance under submission number K897093, 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 1990-04-04.
- Submission: K897093
- Applicant / Sponsor: Microline Pentax, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1990-04-04
Classification & Regulation
This clearance is catalogued under FDA product code HNF and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.