The following data is part of a premarket notification filed by Cormatrix Cardiovascular, Inc. with the FDA for Cormatrix Protect Ecm Envelope.
| Device ID | K140306 |
| 510k Number | K140306 |
| Device Name: | CORMATRIX PROTECT ECM ENVELOPE |
| Classification | Mesh, Surgical |
| Applicant | CORMATRIX CARDIOVASCULAR, INC. 1100 OLD ELLIS ROAD Roswell, GA 30076 |
| Contact | Bryan Brosseau |
| Correspondent | Bryan Brosseau CORMATRIX CARDIOVASCULAR, INC. 1100 OLD ELLIS ROAD Roswell, GA 30076 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-07 |
| Decision Date | 2014-08-15 |
| Summary: | summary |