The following data is part of a premarket notification filed by Mimedx Group, Inc with the FDA for Hydrofix Surgical Sheet.
| Device ID | K100905 |
| 510k Number | K100905 |
| Device Name: | HYDROFIX SURGICAL SHEET |
| Classification | Vessel Guard Or Cover |
| Applicant | MIMEDX GROUP, INC 811 LIVINGSTON COURT SE SUITE B Marietta, GA 30067 |
| Contact | Louise Focht |
| Correspondent | Louise Focht MIMEDX GROUP, INC 811 LIVINGSTON COURT SE SUITE B Marietta, GA 30067 |
| Product Code | OMR |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-01 |
| Decision Date | 2010-06-02 |
| Summary: | summary |