Clearance Summary
ML MICROKERATOME BLADE received FDA 510(k) clearance under submission number K962661, sponsored by Med-Logics, 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 1996-12-09.
- Submission: K962661
- Applicant / Sponsor: Med-Logics, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 1996-12-09
Classification & Regulation
This clearance is catalogued under FDA product code HNO and 21 CFR 886.4370, within the Ophthalmic review panel as a Class I device.