The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh & Co. Kg with the FDA for Palacos R.
Device ID | K030902 |
510k Number | K030902 |
Device Name: | PALACOS R |
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 | 2003-03-24 |
Decision Date | 2003-09-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04260102135505 | K030902 | 000 |
B578001112140011 | K030902 | 000 |