OSTEOPAL V

Bone Cement

HERAEUS KULZER GMBH

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

Pre-market Notification Details

Device IDK050085
510k NumberK050085
Device Name:OSTEOPAL V
ClassificationBone Cement
Applicant HERAEUS KULZER GMBH GRUNER WEG 11 Hanau,  DE 63450
ContactChristian Tuchscherer
CorrespondentChristian Tuchscherer
HERAEUS KULZER GMBH GRUNER WEG 11 Hanau,  DE 63450
Product CodeLOD  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-13
Decision Date2005-09-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260102130326 K050085 000

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