510(k) K003109
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2000
- Date Received
- October 4, 2000
- Clearance Type
- Abbreviated
- 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