The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Geistlich Bio-oss, Geistlich Bio-oss Collagen, Geistlich Combi-kit Collagen, Geistlich Perio System Combi Pack, Geistlic.
| Device ID | K122894 |
| 510k Number | K122894 |
| Device Name: | GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC |
| Classification | Bone Grafting Material, Animal Source |
| Applicant | GEISTLICH PHARMA AG 555 TWELFTH STREET, NW Washington, DC 20004 -1206 |
| Contact | Daniel A Kracov |
| Correspondent | Daniel A Kracov GEISTLICH PHARMA AG 555 TWELFTH STREET, NW Washington, DC 20004 -1206 |
| Product Code | NPM |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-20 |
| Decision Date | 2013-02-15 |
| Summary: | summary |