The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh with the FDA for Osteopal V.
| Device ID | K050085 |
| 510k Number | K050085 |
| Device Name: | OSTEOPAL V |
| Classification | Bone Cement |
| Applicant | HERAEUS KULZER GMBH GRUNER WEG 11 Hanau, DE 63450 |
| Contact | Christian Tuchscherer |
| Correspondent | Christian Tuchscherer HERAEUS KULZER GMBH GRUNER WEG 11 Hanau, DE 63450 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-13 |
| Decision Date | 2005-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260102130326 | K050085 | 000 |