The following data is part of a premarket notification filed by Bridger Biomed, Inc. with the FDA for Dura-patch Model Dp-xxx.
| Device ID | K980548 |
| 510k Number | K980548 |
| Device Name: | DURA-PATCH MODEL DP-XXX |
| Classification | Dura Substitute |
| 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 | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-12 |
| Decision Date | 1998-05-13 |
| Summary: | summary |