510(k) K864594
K864594 is an FDA 510(k) premarket notification submitted by Global Eye Care, Inc. for the device "DUALENZ LOW VISION EYEWEAR". The FDA issued a decision of Substantially Equivalent on January 20, 1987. The device falls under product code HKK (Telescope, Spectacle, Low-Vision), a Class I device regulated under 21 CFR 886.5870.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 1987
- Date Received
- November 21, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Telescope, Spectacle, Low-Vision
- Device Class
- Class I
- Regulation Number
- 886.5870
- Review Panel
- OP
- Submission Type