The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Geistlich Wound Matrix Plus.
| Device ID | K213607 |
| 510k Number | K213607 |
| Device Name: | Geistlich Wound Matrix PLUS |
| Classification | Dressing, Wound, Collagen |
| Applicant | Geistlich Pharma AG Bahnhofstrasse 40 Wolhusen, CH 6110 |
| Contact | Erik Wirth |
| Correspondent | Stephen P Rhodes Streamline Regulatory 3502 Dundee Dr Chevy Chase, MD 20815 |
| 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 | 2021-11-15 |
| Decision Date | 2022-04-28 |