The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Hs Fiber (polyblend), River Bond, Riversilk (silk), Riverpro (polypropylene), Riverlon (nylon) Model Veries By Size/need.
| Device ID | K100006 |
| 510k Number | K100006 |
| Device Name: | HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | RIVERPOINT MEDICAL 825 NE 25TH AVE. Portland, OR 97232 |
| Contact | Doug Rowley |
| Correspondent | Doug Rowley RIVERPOINT MEDICAL 825 NE 25TH AVE. Portland, OR 97232 |
| Product Code | GAT |
| Subsequent Product Code | GAP |
| Subsequent Product Code | GAR |
| Subsequent Product Code | GAS |
| Subsequent Product Code | GAW |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-04 |
| Decision Date | 2010-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20653405002083 | K100006 | 000 |
| M68520053S0 | K100006 | 000 |
| M685200531 | K100006 | 000 |
| M685200501 | K100006 | 000 |
| M68520049S0 | K100006 | 000 |
| M685200491 | K100006 | 000 |
| M68520035S0 | K100006 | 000 |
| M685200351 | K100006 | 000 |
| M68520034S0 | K100006 | 000 |
| M68520032S0 | K100006 | 000 |
| 20653405005480 | K100006 | 000 |
| M685200541 | K100006 | 000 |
| M68520054S0 | K100006 | 000 |
| M685200551 | K100006 | 000 |
| 20653405002052 | K100006 | 000 |
| 20653405002045 | K100006 | 000 |
| M68520188S0 | K100006 | 000 |
| M685201880 | K100006 | 000 |
| M685200601 | K100006 | 000 |
| M68520059S0 | K100006 | 000 |
| M685200591 | K100006 | 000 |
| M68520056S0 | K100006 | 000 |
| M685200561 | K100006 | 000 |
| M68520055S0 | K100006 | 000 |
| 20653405005473 | K100006 | 000 |