The following data is part of a premarket notification filed by Mimedx Group, Inc with the FDA for Hydrofix Surgical Sheet.
| Device ID | K100313 |
| 510k Number | K100313 |
| Device Name: | HYDROFIX SURGICAL SHEET |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | MIMEDX GROUP, INC 811 LIVINGSTON COURT SE SUITE B Marietta, GA 30067 |
| Contact | Sally Thorsen |
| Correspondent | Sally Thorsen MIMEDX GROUP, INC 811 LIVINGSTON COURT SE SUITE B Marietta, GA 30067 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-04 |
| Decision Date | 2011-06-14 |
| Summary: | summary |