510(k) K121675
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 2012
- Date Received
- June 6, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.4150
- Review Panel
- OP
- Submission Type