PALACOS LV+G

Bone Cement

HERAEUS KULZER GMBH

The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh with the FDA for Palacos Lv+g.

Pre-market Notification Details

Device IDK050854
510k NumberK050854
Device Name:PALACOS LV+G
ClassificationBone Cement
Applicant HERAEUS KULZER GMBH PHILLIP REIS-STRASSE 8/13 Wehrheim,  DE D-61273
ContactChristian Tuchscherer
CorrespondentChristian Tuchscherer
HERAEUS KULZER GMBH PHILLIP REIS-STRASSE 8/13 Wehrheim,  DE D-61273
Product CodeLOD  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2005-04-04
Decision Date2005-07-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260102135598 K050854 000
B5780011191400115 K050854 000

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