The following data is part of a premarket notification filed by Mimedx Group, Inc with the FDA for Hydrofix Vaso Shield.
| Device ID | K101805 |
| 510k Number | K101805 |
| Device Name: | HYDROFIX VASO SHIELD |
| Classification | Vessel Guard Or Cover |
| 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 | OMR |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-28 |
| Decision Date | 2011-04-08 |
| Summary: | summary |