DUALENZ LOW VISION EYEWEAR— 510(k) K864594
Substantially EquivalentGlobal Eye Care, Inc.
FDA 510(k) clearance K864594 for DUALENZ LOW VISION EYEWEAR, Substantially Equivalent on 1987-01-20. Applicant: Global Eye Care, Inc..
Clearance details
- Applicant
- Global Eye Care, Inc.
- Product code
- Code HKK
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.