510(k) K161758
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 2016
- Date Received
- June 27, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type