Clearance Summary
STERILIZED DISPOS. CYSTOTOME received FDA 510(k) clearance under submission number K840442, sponsored by Microsurgical Technology, 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 1984-03-16.
- Submission: K840442
- Applicant / Sponsor: Microsurgical Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1984-03-16
Classification & Regulation
This clearance is catalogued under FDA product code HMX and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.