The following data is part of a premarket notification filed by Astra Tech Ab with the FDA for Osseospeed Tm Profile System.
| Device ID | K080156 |
| 510k Number | K080156 |
| Device Name: | OSSEOSPEED TM PROFILE SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ASTRA TECH AB 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Contact | Linda K Schulz |
| Correspondent | Linda K Schulz ASTRA TECH AB 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-23 |
| Decision Date | 2008-09-17 |
| Summary: | summary |