GELENDER VACUUM FIXATION RING SYS
FDA 510(k) clearance K832912 · decided 1984-01-10
Clearance details
- K-number
- K832912
- Device name
- GELENDER VACUUM FIXATION RING SYS
- Applicant
- Miami Eye Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-29
- Decision date
- 1984-01-10
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- HNH
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Miami Eye Technology
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| LANDERS VITRECTOMY LENS RING SYSTEMS (K850991) | Ocular Instruments, Inc. | 1985-03-29 |
Recalls involving this device
No recalls on record reference this clearance.