KODAK 9000C EXTRAORAL IMAGING SYSTEM

System, X-ray, Extraoral Source, Digital

TROPHY

The following data is part of a premarket notification filed by Trophy with the FDA for Kodak 9000c Extraoral Imaging System.

Pre-market Notification Details

Device IDK080889
510k NumberK080889
Device Name:KODAK 9000C EXTRAORAL IMAGING SYSTEM
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant TROPHY 4 RUE F. PELLOUTIER Croissy-beaubourg,  FR 77435
ContactMarie-pierre Labat-camy
CorrespondentMarie-pierre Labat-camy
TROPHY 4 RUE F. PELLOUTIER Croissy-beaubourg,  FR 77435
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-31
Decision Date2008-04-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
60192155211010 K080889 000

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