The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Fiberwire With Silk.
| Device ID | K041589 |
| 510k Number | K041589 |
| Device Name: | ARTHREX FIBERWIRE WITH SILK |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Ann Waterhouse |
| Correspondent | Ann Waterhouse ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-11 |
| Decision Date | 2004-08-05 |
| Summary: | summary |