510(k) K191795
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 2019
- Date Received
- July 3, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Soft Lens Products
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type