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 |