510(k) K140415
K140415 is an FDA 510(k) premarket notification submitted by Riverpoint Medical for the device "MONOTEX". The FDA issued a decision of Substantially Equivalent on March 26, 2014. The device falls under product code NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene), a Class II device regulated under 21 CFR 878.5035. Riverpoint Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2014
- Date Received
- February 18, 2014
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- Device Class
- Class II
- Regulation Number
- 878.5035
- Review Panel
- SU
- Submission Type