The following data is part of a premarket notification filed by Heraeus Medical Gmbh with the FDA for Palacos Fast R+g.
| Device ID | K190766 |
| 510k Number | K190766 |
| Device Name: | PALACOS Fast R+G |
| Classification | Bone Cement |
| Applicant | Heraeus Medical GmbH Philipp-Reis-Strasse 8/13 Wehrheim, DE 61273 |
| Contact | Ute Greiner |
| Correspondent | Ute Greiner Heraeus Medical GmbH Philipp-Reis-Strasse 8/13 Wehrheim, DE 61273 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-03-25 |
| Decision Date | 2019-05-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260102136083 | K190766 | 000 |