PALACOS R

Bone Cement

HERAEUS KULZER GMBH & CO. KG

The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh & Co. Kg with the FDA for Palacos R.

Pre-market Notification Details

Device IDK030902
510k NumberK030902
Device Name:PALACOS R
ClassificationBone Cement
Applicant HERAEUS KULZER GMBH & CO. KG GRUNER WEG 11 Hanau,  DE D-63450
ContactK.d. Kuhn
CorrespondentK.d. Kuhn
HERAEUS KULZER GMBH & CO. KG GRUNER WEG 11 Hanau,  DE D-63450
Product CodeLOD  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-24
Decision Date2003-09-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260102135505 K030902 000
B578001112140011 K030902 000

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