PALAMED G

Bone Cement

HERAEUS KULZER GMBH

The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh with the FDA for Palamed G.

Pre-market Notification Details

Device IDK050855
510k NumberK050855
Device Name:PALAMED 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
04260102135826 K050855 000

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