The following data is part of a premarket notification filed by Geistlich-pharma with the FDA for Bio-oss, Bio-oss Blocks And Bio-oss Collagen.
| Device ID | K033815 |
| 510k Number | K033815 |
| Device Name: | BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN |
| Classification | Bone Grafting Material, Animal Source |
| Applicant | GEISTLICH-PHARMA 1301 K STREET NW SUITE 600, EAST TOWER Washington, DC 20005 |
| Contact | Peter S Reichertz |
| Correspondent | Peter S Reichertz GEISTLICH-PHARMA 1301 K STREET NW SUITE 600, EAST TOWER Washington, DC 20005 |
| Product Code | NPM |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-09 |
| Decision Date | 2004-01-15 |
| Summary: | summary |