510(k) K152795
K152795 is an FDA 510(k) premarket notification submitted by Riverpoint Medical for the device "RiverLon (Nylon) Suture". The FDA issued a decision of Substantially Equivalent on October 28, 2015. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Riverpoint Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2015
- Date Received
- September 28, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyamide
- Device Class
- Class II
- Regulation Number
- 878.5020
- Review Panel
- SU
- Submission Type