The following data is part of a premarket notification filed by Cp Medical with the FDA for Cp-fiber (orthofiber).
| Device ID | K094028 |
| 510k Number | K094028 |
| Device Name: | CP-FIBER (ORTHOFIBER) |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | CP MEDICAL 803 NE 25TH AVE. Portland, OR 97232 |
| Contact | Barbara K Horton |
| Correspondent | Barbara K Horton CP MEDICAL 803 NE 25TH AVE. Portland, OR 97232 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-30 |
| Decision Date | 2010-03-18 |
| Summary: | summary |