The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh with the FDA for Palacos Lv+g.
| Device ID | K050854 |
| 510k Number | K050854 |
| Device Name: | PALACOS LV+G |
| Classification | Bone Cement |
| Applicant | HERAEUS KULZER GMBH PHILLIP REIS-STRASSE 8/13 Wehrheim, DE D-61273 |
| Contact | Christian Tuchscherer |
| Correspondent | Christian Tuchscherer HERAEUS KULZER GMBH PHILLIP REIS-STRASSE 8/13 Wehrheim, DE D-61273 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-04-04 |
| Decision Date | 2005-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260102135598 | K050854 | 000 |
| B5780011191400115 | K050854 | 000 |