The following data is part of a premarket notification filed by Engineered Tissue Solutions, Llc with the FDA for Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”.
| Device ID | K161067 |
| 510k Number | K161067 |
| Device Name: | Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” |
| Classification | Dressing, Wound, Drug |
| Applicant | ENGINEERED TISSUE SOLUTIONS, LLC 4030 HYPOINT NORTH Rolla, MO 65401 |
| Contact | Mark Borden |
| Correspondent | Randy Prebula HOGAN LOVELLS US LLP 555 THIRTEENTH STREET, NW Washington, DC 20009 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-15 |
| Decision Date | 2016-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812005030117 | K161067 | 000 |
| 00812005030377 | K161067 | 000 |
| 00812005030230 | K161067 | 000 |
| 00812005030292 | K161067 | 000 |
| 00812005030346 | K161067 | 000 |
| 00812005030339 | K161067 | 000 |
| B477MWM0106SB1 | K161067 | 000 |
| B477MWM0202SB1 | K161067 | 000 |
| B477MWM0404SB1 | K161067 | 000 |
| 00812005030056 | K161067 | 000 |
| 00812005030254 | K161067 | 000 |