E-Ortho Shoulder Software

System, Image Processing, Radiological

FH Industrie

The following data is part of a premarket notification filed by Fh Industrie with the FDA for E-ortho Shoulder Software.

Pre-market Notification Details

Device IDK201928
510k NumberK201928
Device Name:E-Ortho Shoulder Software
ClassificationSystem, Image Processing, Radiological
Applicant FH Industrie ZI De Kernevez - 6 Rue Nobel Quimper,  FR 29000
ContactOscar Ramirez
CorrespondentDawn Norman
MRC Global, LLC 9085 E. Mineral Circle, Suite 110 Centennial,  CO  80112
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-10
Decision Date2020-09-30

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