The following data is part of a premarket notification filed by Merck Biomaterial Gmbh with the FDA for Palamed Bone Cement.
| Device ID | K010586 |
| 510k Number | K010586 |
| Device Name: | PALAMED BONE CEMENT |
| Classification | Bone Cement |
| Applicant | MERCK BIOMATERIAL GMBH FRANKFURTER STR. 250, D-64271 Darmstadt, DE D-64271 |
| Contact | Thomas Kiewitt |
| Correspondent | Thomas Kiewitt MERCK BIOMATERIAL GMBH FRANKFURTER STR. 250, D-64271 Darmstadt, DE D-64271 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-27 |
| Decision Date | 2001-10-30 |