Clearance Summary
KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA received FDA 510(k) clearance under submission number K850049, sponsored by Xtal Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1985-03-06.
- Submission: K850049
- Applicant / Sponsor: Xtal Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1985-03-06
Classification & Regulation
This clearance is catalogued under FDA product code HNN and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.