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 |