510(k) K080632
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2008
- Date Received
- March 5, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Contact, (Disposable)
- Device Class
- Class II
- Regulation Number
- 886.5925
- Review Panel
- OP
- Submission Type