The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh & Co. Kg with the FDA for Refobacin -palacos G.
| Device ID | K031673 |
| 510k Number | K031673 |
| Device Name: | REFOBACIN -PALACOS G |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-05-30 |
| Decision Date | 2004-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260102135536 | K031673 | 000 |
| B578001113140011 | K031673 | 000 |