Clearance Summary
PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI received FDA 510(k) clearance under submission number K013337, sponsored by Surgin, 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 2001-12-13.
- Submission: K013337
- Applicant / Sponsor: Surgin, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 2001-12-13
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.