510(k) K170520
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 2017
- Date Received
- February 22, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vitrectomy, Instrument Cutter
- Device Class
- Class II
- Regulation Number
- 886.4150
- Review Panel
- OP
- Submission Type