The following data is part of a premarket notification filed by Bridger Biomed, Inc. with the FDA for Modification To Fluorotex Ii Surgical Mesh.
| Device ID | K003917 |
| 510k Number | K003917 |
| Device Name: | MODIFICATION TO FLUOROTEX II SURGICAL MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | BRIDGER BIOMED, INC. 2430 NORTH 7TH AVE., SUITE 4 Bozeman, MT 59715 |
| Contact | Bruce G Ruefer |
| Correspondent | Bruce G Ruefer BRIDGER BIOMED, INC. 2430 NORTH 7TH AVE., SUITE 4 Bozeman, MT 59715 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-19 |
| Decision Date | 2001-01-26 |