Clearance Summary
PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES) received FDA 510(k) clearance under submission number K970377, sponsored by Plancon Instruments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1997-03-31.
- Submission: K970377
- Applicant / Sponsor: Plancon Instruments
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 1997-03-31
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.