The following data is part of a premarket notification filed by Synovis Surgical Innovations with the FDA for Veritas Dry Collagen Matrix, Veritas Dry Or Veritas Psd.
Device ID | K041669 |
510k Number | K041669 |
Device Name: | VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD |
Classification | Mesh, Surgical |
Applicant | SYNOVIS SURGICAL INNOVATIONS 2575 UNIVERSITY AVE. WEST St. Paul, MN 55114 -1024 |
Contact | James Jenkins |
Correspondent | James Jenkins SYNOVIS SURGICAL INNOVATIONS 2575 UNIVERSITY AVE. WEST 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 | 2004-06-21 |
Decision Date | 2004-10-27 |
Summary: | summary |