The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh & Co. Kg with the FDA for Palabond.
Device ID | K022251 |
510k Number | K022251 |
Device Name: | PALABOND |
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 | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-12 |
Decision Date | 2003-02-26 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PALABOND 76048256 2566653 Live/Registered |
KULZER GMBH 2000-05-12 |