510(k) K083216
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 2009
- Date Received
- October 31, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lenses, Soft Contact, Daily Wear
- Device Class
- Class II
- Regulation Number
- 886.5925
- Review Panel
- OP
- Submission Type