510(k) K864594
- Device
- DUALENZ LOW VISION EYEWEAR
- Applicant
- GLOBAL EYE CARE, INC.
- 510(k) number
- K864594
- Product code
- HKK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-01-20
- Date received
- 1986-11-21
- Regulation
- 886.5870
- Classification name
- Telescope, Spectacle, Low-vision
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES C BRADFORD
- Address
- 2133 Buffalo Rd. Rochester NY US 14624 14624
FDA Registration Numbers#
- 3012724515
- 2431764
- 3009555547
- 3002968900
- 3008309602
- 9617474
- 3003951061
- 3041277555
- 2521877
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HKK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K870203 | KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5 | Keeler Instruments, Inc. | 1987-02-12 |
Legacy Summary#
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FDA Review#
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