The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Geistlich Bio-oss Pen (0.25 G, 0.25-1.0mm Granules), Geistlich Bio-oss Pen (0.5 G, 0.25-1.0mm Granules), Geistlich Bio-o.
| Device ID | K120601 |
| 510k Number | K120601 |
| Device Name: | GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O |
| 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 | 2012-02-28 |
| Decision Date | 2012-05-24 |
| Summary: | summary |