DUALENZ LOW VISION EYEWEAR
FDA 510(k) clearance K864594 · decided 1987-01-20
Clearance details
- K-number
- K864594
- Device name
- DUALENZ LOW VISION EYEWEAR
- Applicant
- Global Eye Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-11-21
- Decision date
- 1987-01-20
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- HKK
- Device class
- 1
- Regulation number
- 886.5870
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rochester, NY, 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 |
|---|---|---|
| KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5 (K870203) | Keeler Instruments, Inc. | 1987-02-12 |
Recalls involving this device
No recalls on record reference this clearance.