The following data is part of a premarket notification filed by Heraeus Medical Gmbh Technology with the FDA for Palamed.
| Device ID | K030904 |
| 510k Number | K030904 |
| Device Name: | PALAMED |
| Classification | Bone Cement |
| Applicant | Heraeus Medical Gmbh Technology Philipp-Reis Strabe 8/13 Wehrheim, DE 61273 |
| Contact | Karen Liu |
| Correspondent | Karen Liu Heraeus Medical GmbH Technology Philipp-Reis-Strabe 8/13 Wehrheim, DE 61273 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-24 |
| Decision Date | 2003-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260102135857 | K030904 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PALAMED 75300869 2208322 Dead/Cancelled |
HERAEUS KULZER GMBH 1997-05-30 |