The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Geistlich Combi-kit Collegen.
| Device ID | K112572 |
| 510k Number | K112572 |
| Device Name: | GEISTLICH COMBI-KIT COLLEGEN |
| 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 | 2011-09-06 |
| Decision Date | 2011-12-28 |
| Summary: | summary |