The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Geistlich Bio-gide, Geistlich Bio-gide Shape, Geistlich Bio-gide Compressed, Geistlich Bio-gide Perio, Geistlich Combi-kit Collagen, Geistlich Perio-system Combi-pack, Geistlich Mucograft And Geistlich Mucograft Seal.
| Device ID | K192042 |
| 510k Number | K192042 |
| Device Name: | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft And 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 | 2019-07-31 |
| Decision Date | 2019-08-29 |