The following data is part of a premarket notification filed by Synovis Surgical Innovations with the FDA for Veritas Collagen Matrix.
Device ID | K030879 |
510k Number | K030879 |
Device Name: | VERITAS COLLAGEN MATRIX |
Classification | Mesh, Surgical, Collagen, Staple Line Reinforcement |
Applicant | SYNOVIS SURGICAL INNOVATIONS 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
Contact | Angela Mallery |
Correspondent | Angela Mallery SYNOVIS SURGICAL INNOVATIONS 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
Product Code | OXE |
Subsequent Product Code | FTM |
Subsequent Product Code | OWV |
Subsequent Product Code | OXB |
Subsequent Product Code | PAJ |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-20 |
Decision Date | 2003-04-24 |
Summary: | summary |