Orthodontic Software

Software Nemotec S.L.

The following data is part of a premarket notification filed by Software Nemotec S.l. with the FDA for Nemocast.

Pre-market Notification Details

Device IDK193003
510k NumberK193003
Device Name:NemoCast
ClassificationOrthodontic Software
Applicant Software Nemotec S.L. Juan De La Cierva Street, 66 Arroyomolinos, Madrid,  ES 28939
ContactCarlos Arias
CorrespondentKevin Walls
Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton,  CO  80127
Product CodePNN  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-28
Decision Date2020-06-05

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