CS 9300, CS 9300C

X-ray, Tomography, Computed, Dental

TROPHY

The following data is part of a premarket notification filed by Trophy with the FDA for Cs 9300, Cs 9300c.

Pre-market Notification Details

Device IDK103659
510k NumberK103659
Device Name:CS 9300, CS 9300C
ClassificationX-ray, Tomography, Computed, Dental
Applicant TROPHY 4 RUE F. PELLOUTIER CROISSY BEAUBOURG Marne La Vallee Cedex 2,  FR 77437
ContactMarie-pierre Labat-camy
CorrespondentMarie-pierre Labat-camy
TROPHY 4 RUE F. PELLOUTIER CROISSY BEAUBOURG Marne La Vallee Cedex 2,  FR 77437
Product CodeOAS  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-15
Decision Date2011-08-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
60192155319747 K103659 000
60192155319730 K103659 000
60192155319723 K103659 000
60192155319716 K103659 000
60192155319693 K103659 000
60192155319686 K103659 000

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