PALACOS R Pro

Bone Cement

HERAEUS MEDICAL GMBH

The following data is part of a premarket notification filed by Heraeus Medical Gmbh with the FDA for Palacos R Pro.

Pre-market Notification Details

Device IDK150119
510k NumberK150119
Device Name:PALACOS R Pro
ClassificationBone Cement
Applicant HERAEUS MEDICAL GMBH PHILIPP-REIS-STR. 8-13 Wehrheim,  DE 61273
ContactAstrid Marx
CorrespondentTina Wu-murphy
ICON Plc 62 Forest Street Suite 300 Marlborough,  MA  01752
Product CodeLOD  
Subsequent Product CodeJDZ
Subsequent Product CodeKIH
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-20
Decision Date2015-06-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260102135970 K150119 000

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