The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Supple Peri-guard Pericardium.
Device ID | K961810 |
510k Number | K961810 |
Device Name: | SUPPLE 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 |