Clearance Summary
MECHANICAL CYSTITOME received FDA 510(k) clearance under submission number K862709, sponsored by Rudolph Beaver, 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 1986-08-01.
- Submission: K862709
- Applicant / Sponsor: Rudolph Beaver, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1986-08-01
Classification & Regulation
This clearance is catalogued under FDA product code HNY and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.