510(k) K112192
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2011
- Date Received
- July 29, 2011
- Clearance Type
- Special
- 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