The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Supple Peri-guard.
| Device ID | K923657 |
| 510k Number | K923657 |
| Device Name: | SUPPLE PERI-GUARD |
| Classification | Mesh, Surgical |
| 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 | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-27 |
| Decision Date | 1992-12-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SUPPLE PERI-GUARD 87439184 not registered Live/Pending |
Synovis Life Technologies, Inc. 2017-05-05 |
![]() SUPPLE PERI-GUARD 86072368 not registered Dead/Abandoned |
Synovis Life Technologies, Inc. 2013-09-23 |
![]() SUPPLE PERI-GUARD 74731826 2008127 Live/Registered |
SYNOVIS LIFE TECHNOLOGIES, INC. 1995-09-21 |