Clearance Summary
PRIZM KERATOME BLADE, MODEL MK8512M2 received FDA 510(k) clearance under submission number K033236, sponsored by Surgin Surgical Instrumentation, 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 2004-03-26.
- Submission: K033236
- Applicant / Sponsor: Surgin Surgical Instrumentation, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 2004-03-26
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.