The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh & Co. Kg with the FDA for Palabond.
| Device ID | K022251 |
| 510k Number | K022251 |
| Device Name: | PALABOND |
| Classification | Bone Cement |
| Applicant | HERAEUS KULZER GMBH & CO. KG GRUNER WEG 11 Hanau, DE D-63450 |
| Contact | K. D. Kuhn |
| Correspondent | K. D. Kuhn HERAEUS KULZER GMBH & CO. KG GRUNER WEG 11 Hanau, DE D-63450 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-12 |
| Decision Date | 2003-02-26 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PALABOND 76048256 2566653 Live/Registered |
KULZER GMBH 2000-05-12 |