510(k) K031753
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2004
- Date Received
- June 5, 2003
- Clearance Type
- Traditional
- 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