510(k) K132216
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2013
- Date Received
- July 17, 2013
- 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