The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Hs Fiber.
| Device ID | K190817 |
| 510k Number | K190817 |
| Device Name: | HS Fiber |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Riverpoint Medical 825 NE 25th Ave. Portland, OR 97232 |
| Contact | Edwin Anderson |
| Correspondent | Edwin Anderson Riverpoint Medical 825 NE 25th Ave. Portland, OR 97232 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-01 |
| Decision Date | 2019-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M68520189S0 | K190817 | 000 |
| M685201890 | K190817 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HS FIBER 85392505 4125447 Live/Registered |
RIVERPOINT MEDICAL, LLC 2011-08-08 |