LANDERS VITRECTOMY LENS RING SYSTEMS
FDA 510(k) clearance K850991 · decided 1985-03-29
Clearance details
- K-number
- K850991
- Device name
- LANDERS VITRECTOMY LENS RING SYSTEMS
- Applicant
- Ocular Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-03-11
- Decision date
- 1985-03-29
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- HNH
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Bellevue, WA, 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 |
|---|---|---|
| LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING (K912269) | Ocular Instruments, Inc. | 1991-08-07 |
| LANDERS NOTCHED VITRECTOMY LENS RING (K912268) | Ocular Instruments, Inc. | 1991-08-07 |
| LANDERS THREE STRUT VITRECTOMY LENS RING (K912151) | Ocular Instruments, Inc. | 1991-07-25 |
| LANDERS VITRECTOMY LENS RING W/INFUSION (K902496) | Ocular Instruments, Inc. | 1990-07-24 |
| RK VACUUM FIXATION RING SYSTEM (K863775) | Ameritek, Inc. | 1986-10-20 |
| GELENDER VACUUM FIXATION RING SYS (K832912) | Miami Eye Technology, Inc. | 1984-01-10 |
Recalls involving this device
No recalls on record reference this clearance.