510(k) K151009
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2015
- Date Received
- April 15, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Device Class
- Class II
- Regulation Number
- 878.5000
- Review Panel
- SU
- Submission Type