The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh with the FDA for Palacos Lv+g.
Device ID | K050854 |
510k Number | K050854 |
Device Name: | PALACOS LV+G |
Classification | Bone Cement |
Applicant | HERAEUS KULZER GMBH PHILLIP REIS-STRASSE 8/13 Wehrheim, DE D-61273 |
Contact | Christian Tuchscherer |
Correspondent | Christian Tuchscherer HERAEUS KULZER GMBH PHILLIP REIS-STRASSE 8/13 Wehrheim, DE D-61273 |
Product Code | LOD |
CFR Regulation Number | 888.3027 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2005-04-04 |
Decision Date | 2005-07-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04260102135598 | K050854 | 000 |
B5780011191400115 | K050854 | 000 |