The following data is part of a premarket notification filed by Carbon Medical Technologies, Inc. with the FDA for Dermmatrix Surgical Mesh.
| Device ID | K021160 |
| 510k Number | K021160 |
| Device Name: | DERMMATRIX SURGICAL MESH |
| Classification | Mesh, Surgical |
| Applicant | CARBON MEDICAL TECHNOLOGIES, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Contact | Karen E Peterson |
| Correspondent | Karen E Peterson CARBON MEDICAL TECHNOLOGIES, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-11 |
| Decision Date | 2002-06-12 |
| Summary: | summary |