The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Geistlich Mucograft®, Geistlich Mucograft® Seal.
| Device ID | K210280 |
| 510k Number | K210280 |
| Device Name: | Geistlich Mucograft®, Geistlich Mucograft® Seal |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | Geistlich Pharma AG Bahnhofstrasse 40 Wolhusen, CH Ch-6110 |
| Contact | Marco Steiner |
| Correspondent | Roshana Ahmed TELOS Partners LLC 571 Christina Lake Drive Lakeland, FL 33813 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-01 |
| Decision Date | 2021-03-03 |