The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Riverlon (nylon) Suture.
| Device ID | K152795 |
| 510k Number | K152795 |
| Device Name: | RiverLon (Nylon) Suture |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | RIVERPOINT MEDICAL 825 NE 25TH AVENUE Portland, OR 97232 |
| Contact | Edwin Anderson |
| Correspondent | Edwin Anderson RIVERPOINT MEDICAL 825 NE 25TH AVENUE Portland, OR 97232 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-28 |
| Decision Date | 2015-10-28 |
| Summary: | summary |