510(k) K110166
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2011
- Date Received
- January 20, 2011
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Knife, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type