Clearance Summary
OCULAR IRRIGATING CANNULA received FDA 510(k) clearance under submission number K831532, sponsored by Dey Laboratories, 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 1983-07-12.
- Submission: K831532
- Applicant / Sponsor: Dey Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1983-07-12
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.