RARE-EARTH INTRA-OCULAR MAGNET
FDA 510(k) clearance K831702 · decided 1983-06-30
Clearance details
- K-number
- K831702
- Device name
- RARE-EARTH INTRA-OCULAR MAGNET
- Applicant
- Miami Eye Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-05-25
- Decision date
- 1983-06-30
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- HPN
- Device class
- 1
- Regulation number
- 886.4445
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EYE SEE INSTRUMENT (K905237) | King Tool, Inc. | 1991-02-14 |
| H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR (K896473) | Emory University School of Medicine | 1990-02-09 |
| PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG (K880855) | Richard James, Inc. | 1988-04-01 |
| RARE EARTH INTRA-OCULAR MAGNET (K860960) | Ameritek, Inc. | 1986-03-31 |
Recalls involving this device
No recalls on record reference this clearance.