The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Geistlich Perio-system Combi-pack , Geistlich Bio-gide Perio.
| Device ID | K112575 |
| 510k Number | K112575 |
| Device Name: | GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO |
| 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 | 2011-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07610221010394 | K112575 | 000 |