The following data is part of a premarket notification filed by Miromatrix Medical Inc. with the FDA for Miromatrix Biological Mesh.
| Device ID | K134033 |
| 510k Number | K134033 |
| Device Name: | MIROMATRIX BIOLOGICAL MESH |
| Classification | Mesh, Surgical |
| Applicant | MIROMATRIX MEDICAL INC. 400 N. WASHINGTON ST., STE 100 Alexandria, VA 22314 |
| Contact | Stephen Rhodes |
| Correspondent | Stephen Rhodes MIROMATRIX MEDICAL INC. 400 N. WASHINGTON ST., STE 100 Alexandria, VA 22314 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-31 |
| Decision Date | 2014-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857072005057 | K134033 | 000 |
| 00857072005040 | K134033 | 000 |
| 00857072005033 | K134033 | 000 |
| 00857072005026 | K134033 | 000 |
| 00857072005019 | K134033 | 000 |
| 00857072005002 | K134033 | 000 |