The following data is part of a premarket notification filed by Heraeus Medical Gmbh with the FDA for Palacos R Pro.
| Device ID | K150119 |
| 510k Number | K150119 |
| Device Name: | PALACOS R Pro |
| Classification | Bone Cement |
| Applicant | HERAEUS MEDICAL GMBH PHILIPP-REIS-STR. 8-13 Wehrheim, DE 61273 |
| Contact | Astrid Marx |
| Correspondent | Tina Wu-murphy ICON Plc 62 Forest Street Suite 300 Marlborough, MA 01752 |
| Product Code | LOD |
| Subsequent Product Code | JDZ |
| Subsequent Product Code | KIH |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-20 |
| Decision Date | 2015-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260102135970 | K150119 | 000 |