The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Peri-guard Pericardium.
| Device ID | K961811 |
| 510k Number | K961811 |
| Device Name: | PERI-GUARD PERICARDIUM |
| Classification | Mesh, Surgical |
| Applicant | BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Contact | Bruce A Macfarlane |
| Correspondent | Bruce A Macfarlane BIO-VASCULAR, INC. 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-10 |
| Decision Date | 1996-06-13 |
| Summary: | summary |