The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Dura-guard-dural Repair Patch.
| Device ID | K973706 |
| 510k Number | K973706 |
| Device Name: | DURA-GUARD-DURAL REPAIR PATCH |
| Classification | Dura Substitute |
| Applicant | BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Contact | Barbara Atzenhoefer |
| Correspondent | Barbara Atzenhoefer BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-29 |
| Decision Date | 1997-12-24 |
| Summary: | summary |