The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Nexo-gide Bilayer Collagen Membrane.
| Device ID | K203496 |
| 510k Number | K203496 |
| Device Name: | Nexo-Gide Bilayer Collagen Membrane |
| Classification | Mesh, Surgical |
| Applicant | Geistlich Pharma AG Bahnhofstrasse 40 Wolhusen, CH 6110 |
| Contact | Marco Steiner |
| Correspondent | Joshua Crist Biologics Consulting 1555 King Street, Suite 300 Alexandria, VA 22314 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-27 |
| Decision Date | 2021-07-14 |