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 |