Rare-Earth Intra-Ocular Magnet
FDA 510(k) K831702 · Miami Eye Technology, Inc.
510(k) numberK831702
Submission
- Device name
- Rare-Earth Intra-Ocular Magnet
- Applicant
- Miami Eye Technology, Inc.
Mchenry, IL, US - Received
- May 25, 1983
- Decision date
- June 30, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HPN – Magnet, Permanent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4445
- Specialty
- Ophthalmic
Other 510(k)s with product code HPN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K905237 | Eye See InstrumentHPN · Traditional | King Tool, Inc. | 02/14/1991SE |
| K896473 | H200 Hanna Suction Trephine System for Corneal SurHPN · Traditional | Emory University School of Medicine | 02/09/1990SE |
| K880855 | Parel Rare Earth Magnet, I.O.M., Intraocular MagHPN · Traditional | Richard James, Inc. | 04/01/1988SE |
| K860960 | Rare Earth Intra-Ocular MagnetHPN · Traditional | Ameritek, Inc. | 03/31/1986SE |
More from Ameritek, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841101 | Clayman-Parel Capsule CoupeurHNY · Traditional | 05/16/1984SE |
| K832912 | Gelender Vacuum Fixation Ring SysHNH · Traditional | 01/10/1984SE |
| K832996 | Surgical Iop MonitorHKY · Traditional | 11/28/1983SE |
| K832997 | Epa Automated Infusion PoleHQC · Traditional | 10/04/1983SE |
| K832911 | Abbott Globe HolderHJO · Traditional | 09/29/1983SE |
Questions and answers
When was Rare-Earth Intra-Ocular Magnet cleared by the FDA?
Rare-Earth Intra-Ocular Magnet (K831702) received a 510(k) decision of Substantially Equivalent on June 30, 1983, 36 days after the submission was received.
What is the product code of K831702?
The FDA product code is HPN – Magnet, Permanent, a Class I (low risk) device regulated under 21 CFR 886.4445.