The following data is part of a premarket notification filed by Viscus Biologics Llc with the FDA for Xenomem Wound Matrix.
| Device ID | K140820 |
| 510k Number | K140820 |
| Device Name: | XENOMEM WOUND MATRIX |
| Classification | Dressing, Wound, Collagen |
| Applicant | VISCUS BIOLOGICS LLC P.O.BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan VISCUS BIOLOGICS LLC P.O.BOX 560 Stillwater, MN 55082 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-01 |
| Decision Date | 2015-06-26 |
| Summary: | summary |