510(k) K171005
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2017
- Date Received
- April 4, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polypropylene
- Device Class
- Class II
- Regulation Number
- 878.5010
- Review Panel
- SU
- Submission Type