The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Dura-guard Dural Repair Patch, Dura-guard Dura Substitute.
| Device ID | K950956 |
| 510k Number | K950956 |
| Device Name: | DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE |
| Classification | Dura Substitute |
| Applicant | BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
| Contact | Bruce A Macfarlane |
| Correspondent | Bruce A Macfarlane BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul, MN 55113 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-02 |
| Decision Date | 1995-06-02 |