SIMPLANT DR. JAMES

System, Image Processing, Radiological

MATERIALISE N.V.

The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Simplant Dr. James.

Pre-market Notification Details

Device IDK053592
510k NumberK053592
Device Name:SIMPLANT DR. JAMES
ClassificationSystem, Image Processing, Radiological
Applicant MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven,  BE 3001
ContactCarl Van Lierde
CorrespondentCarl Van Lierde
MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven,  BE 3001
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-23
Decision Date2006-02-08
Summary:summary

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