OPHTEC RUST RING REMOVER
FDA 510(k) clearance K834354 · decided 1984-03-19
Clearance details
- K-number
- K834354
- Device name
- OPHTEC RUST RING REMOVER
- Applicant
- Jedmed Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-13
- Decision date
- 1984-03-19
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- HOG
- Device class
- 1
- Regulation number
- 886.4070
- 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 |
|---|---|---|
| AMOILS EPITHELIAL SCRUBBER (K962989) | S. Percy Amoils | 1997-01-09 |
| PALLIKARIS BRUSH (K960261) | Alcon Laboratories, Inc. | 1996-03-11 |
| BURR, CORNEAL, BATTERY-POWERED (K950520) | Aaron Medical Industries | 1995-05-02 |
| GY-RO SAFE (K883785) | Gy-Ro Industry, Inc. | 1989-01-05 |
Recalls involving this device
No recalls on record reference this clearance.