EVANS ARM AND HAND REST
FDA 510(k) clearance K760697 · decided 1976-11-02
Clearance details
- K-number
- K760697
- Device name
- EVANS ARM AND HAND REST
- Applicant
- Alcon Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1976-09-22
- Decision date
- 1976-11-02
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- HRK
- Device class
- 1
- Regulation number
- 886.4855
- 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 |
|---|---|---|
| AMER. EDWARDS LAB FLEXISCOPE (K842410) | American Edwards Laboratories | 1984-11-05 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System; DISCOVISC Ophthalmic Viscosurgical D (P840064/S091) | Alcon Laboratories | 2025-10-03 |
| VISCOAT Ophthalmic Viscosurgical Device, DISCOVISC Ophthalmic Viscosurgical Device (P840064/S090) | Alcon Laboratories | 2025-07-25 |
| DISCOVISC Ophthalmic Viscosurgical Device (P840064/S088) | Alcon Laboratories | 2025-02-26 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), DIS (P840064/S086) | Alcon Laboratories | 2024-08-12 |
| PMMA Single-Piece Anterior Chamber IOL (P880087/S033) | Alcon Laboratories | 2024-06-20 |
| PMMA Multiple and Single-Piece Posterior Chamber IOLs (P840060/S051) | Alcon Laboratories | 2024-06-20 |
| PMMA Multiple and Single-Piece Posterior Chamber IOLs (P810032/S071) | Alcon Laboratories | 2024-06-20 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System, DISCOVISC Ophthalmic Viscosurgical (P840064/S085) | Alcon Laboratories | 2024-06-17 |